Medical device alert: Sprint Fidelis implantable cardioverter defibrillator (ICD) lead - reports of lead conductor fracture

(Medtronic) 23 reports of lead conductor fracture for models (6930, 6931, 6948 and 6949), of around 6,900 leads in the UK including an investigation into a fatality. (MDA/2007/078)

Issued: 19 October 2007 at 11:00

Ref: MDA/2007/078

Action deadlines for the Safety Alert Broadcast System (SABS) Deadline (action underway): 31 October 2007, Deadline (action complete): 28 December 2007

Device

Implantable cardioverter defibrillator (ICD) lead. Sprint Fidelis manufactured by Medtronic, model numbers: 6930, 6931, 6948 and 6949.

Problem

ICD lead recall due to risk of inappropriate patient shocks, loss of defibrillation therapy and/or loss of pacing output, caused by fracture of the lead conductor.

The MHRA has received 23 reports of lead conductor fracture for the above models (6930, 6931, 6948 6949), among approximately 6900 leads distributed in the UK. This includes one ongoing investigation of a fatality which may have been a consequence of lead fracture. Fractures typically occur at two main sites on the lead: one at the ring electrode affecting the anode conductor; the second near the anchoring sleeve tie-down affecting the cathode conductor and occasionally the high voltage conductor.

UK incident reports have included:

  • delivering a number of inappropriate shocks
  • oversensing caused by noise on the lead
  • an increase in the pace/sense or shock lead impedance

Medtronic has informed the MHRA that it is suspending distribution of all models of the Sprint Fidelis lead and is recalling all un-implanted stock. The company communicated this to all its customers in its ‘Urgent Medical Device Information’ issued on 15 October 2007. This provides important programming advice to help increase the chance of early detection of lead fracture, and reduce the risk of inappropriate therapy. However, it is important to note that all ICD leads, not only Medtronic’s Sprint Fidelis models, are associated with a small risk of conductor fracture once implanted, and the steps identified in Medtronic’s notice would not necessarily identify fractures in all cases.

Medtronic had previously issued a ‘Physician Information Letter’ on this lead family in March 2007. Their investigations at that time concluded that variables within the implant procedure may pre-dispose the lead to fracture, with severe bending or kinking of the lead during implantation using the venous access location identified as a risk factor.

Action

  • Do not implant any Sprint Fidelis ICD leads (models listed above).
  • Identify and return to Medtronic any of these leads which have not been implanted.
  • Identify all patients implanted with affected models and arrange a follow-up as soon as practicable (within 8 weeks).
  • Ensure programming parameters are set to maximise the chance of detecting lead fractures and avoiding inappropriate therapy (in accordance with manufacturer’s advice).
  • Remind patients of the importance of contacting their follow-up clinic as soon as possible in the event of therapy delivery and/or the onset of any audible patient alert.
  • Follow up patients at 3-month intervals.

Clinicians should

  • Follow up all patients as soon as practicable, ideally within eight weeks.
    • Review the following parameters which can indicate lead fracture:
      • number of inappropriate shocks
      • oversensing and noise on the RV Lead
      • an increase in the lead impedance
      • an increase in the noise sensing on the noise integrity counter.
    • Consider provocative testing (eg shoulder/arm movements, and deep respiration by the patient), which may help confirm a suspected lead fracture, although this diagnostic method should not be relied upon alone.
    • Programme the patient’s ICD where appropriate to the following parameters as outlined in Medtronic’s ‘Urgent Medical Device Information’: To reduce inappropriate shocks due to oversensing:
      • Program VF detection for initial number of intervals to detect (NID) to nominal settings (18/24) or longer at clinical discretion and redetect NID to nominal settings of (12/16).
      • Where clinically appropriate increase the number of intervals to detect in the VT zones.

        To increase the chance of detection of lead fracture

      • Turn ON patient alert pacing, RV and SVC defibrillation impedance.
      • To optimise effectiveness of the lead impedance alert:
        • Review V pacing lead performance trend to determine typical chronic impedance value for the patient (typical values for Fidelis leads should be 350-1,000 ohms).
        • Programme lead impedance alert threshold for RV pacing to 1,000 ohms if the typical chronic impedance for the patient is ≤ 700 ohms, or
        • Programme lead impedance alert threshold for RV pacing to 1,500 ohms if the typical chronic impedance for the patient is > 700 ohms.
        • Programme lead impedance alert threshold for RV defibrillation and SVC defibrillation to 100 ohms.

Remind patients to contact their follow-up centre immediately after they have received a delivery of therapy or when they are alerted by a ‘BEEP’ from their patient alert.

Follow up patients at 3-month intervals, in line with Medtronic’s standard patient follow-up recommendation in their ICD physicians’ manuals.

Consider the relative risks of lead extraction against the risk of lead fracture on an individual patient basis. Replacement of fully functioning leads would not be appropriate except in unusual circumstances, in view of the significant risk associated with this procedure. However, it is important to note that the actions listed above can not be guaranteed to detect lead fractures in all cases.

Report all instances of lead fracture to the MHRA and Medtronic.

Report explants to the National Pacing and ICD Database (see contact on page 3).

Action by

All cardiologists, cardiothoracic surgeons and cardiac physiologists who implant any of these leads or manage patients implanted with them.

Distribution

Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:

SABS liaison officers for onward distributionto all relevant staff including:

  • A&E departments
  • Cardiac physiologists
  • Cardiologists
  • Cardiology departments
  • Cardiology nurses
  • Cardiothoracic surgeons
  • Clinical governance leads
  • Coronary care nurses
  • Coronary care units
  • Directors of cardiology
  • Directors of nursing
  • Directors of paediatric medicine
  • Medical directors
  • Paediatric intensive care units
  • Risk managers

Healthcare Commission (CHAI) to:Headquarters for onward distribution to:

  • Hospitals in the independent sector

Primary care trusts to:

SABS liaison officers for onward distribution to all relevant staff including:

  • Directors of public health

Contacts

Enquiries to the manufacturer should be addressed to:

Mr David Dunham
Medtronic Limited
Suite One
Sherbourne House
Croxley Business Centre
Watford WD18 8WW

Tel: 01923 212 213
Fax: 01923 241 004

E-mail: david.dunham@medtronic.com

National Pacing and ICD Database
PO Box 9205
Bridge of Weir
Strathclyde
PA11 3DZ

Tel : 01505 612 829
Fax : 01505 612 829

E-mail: morag.cunningham@ic.nhs.uk

Enquiries to the MHRA should quote reference number 2007/001/008/291/012 and be addressed to:

Technical aspects

Samantha Baxter/Hazel Randall/Catherine Scanlan
Medicines & Healthcare products Regulatory Agency
Market Towers1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3242 / 3287 / 3223
Fax: 020 7084 3106

E-mail: sam.baxter@mhra.gsi.gov.uk hazel.randall@mhra.gsi.gov.uk catherine.scanlan@mhra.gsi.gov.uk

Clinical aspects

Dr Susanne Ludgate
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3123
Fax: 020 7084 3111

E-mail: susanne.ludgate@mhra.gsi.gov.uk

Enquiries to the manufacturer should be addressed to:

Change of address or removal from address list for CSCI and Healthcare Commission:

Healthcare Commission
Finsbury Tower
103-105 Bunhill Row
London
EC1Y 8TG

Tel: 020 7448 0842

E-mail: contacts@healthcarecommission.org.uk

How to report adverse incidents

Incidents relating to medical devices must be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) as soon as possible.

Further information about reporting incidents; online incident reporting facilities; and downloadable report forms are available from MHRA’s website (http://www.mhra.gov.uk).

Alternatively, further information and printed incident report forms are available from:

MHRA Adverse Incident Centre
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

Telephone 020 7084 3080 or Fax 020 7084 3109 or e-mail: aic@mhra.gsi.gov.uk(An answerphone service operates outside normal officer hours)

Medical Device Alerts are available in full text on the MHRA website:http://www.mhra.gov.uk

Further information about SABS can be found at www.info.doh.gov.uk/sar2/cmopatie.nsf

Help us improve GOV.UK

Don’t include personal or financial information like your National Insurance number or credit card details.