Deadline (Action underway): 09 October 2004 - Action plan to be agreed and actions started.
Deadline (Action complete): 09 December 2004 - All actions to be completed.
Medtronic implantable cardioverter defibrillator (ICD) models GEM® DR 7271 and Micro Jewel® II 7223Cx.
Medtronic GEM® DR and Micro Jewel® II ICDs manufactured with suspect capacitors and having serial numbers as indicated in Appendix 2.
Extended charge times and inability to deliver therapy at battery voltages close to Elective Replacement Indicator (ERI) for a subset of the above devices.
Since 1999 Medtronic has issued a series of advisory notices concerning the performance of some GEM® DR and Micro Jewel® II ICDs.
Medtronic’s most recent Advisory Notice is appended to this alert and updates previous follow-up recommendations for affected GEM® DR and Micro Jewel® II ICDs. This most recent advisory notice followed receipt of reports in which appropriate therapy had not been delivered during cardiac arrhythmias. Medtronic was concerned that these devices may not be capable of delivering adequate high voltage defibrillation therapy at or near the specified ERI at 4.91V, or during the following period to end of life (EOL), specified at 4.57V. The MHRA is publishing this Medical Device Alert to reiterate the recommendations made by Medtronic, and to update and replace advice previously issued by the Medical Devices Agency in PTN No. 80.
Carry out the following actions for all affected patients (refer to list of serial numbers):
Verify the ICD’s battery voltage and capacitor charge time.
Schedule replacement for any device if either of the following conditions occur:
battery voltage of 5.16V or less,
charge time of 18 seconds or greater.
If the battery voltage is greater than 5.16 volts and the charge time is greater than 14 seconds, program the Automatic Capacitor Formation interval to one month.
If the battery voltage is greater than 5.16 volts and the charge time is less than 14 seconds, or if the Automatic Capacitor Formation is already programmed to one month, no additional reprogramming is required.
Continue to monitor battery voltage and charge times at intervals of not greater than three months.
- Note that the recommendations in this update supersede the advice given in Pacemaker Technical Note (PTN No. 80 issued by the Medical Devices Agency in October 1999.
- Identify patients affected by referring to the serial numbers listed in Appendix 2.
- Follow the detailed instructions given in Medtronic’s Advisory Notice (see Appendix 1).
FEEDBACK REQUIREMENTS: Report all instances in which a device has failed to deliver therapy (with a note of the battery voltage and charge time) to MHRA and Medtronic. Report explants to the National Pacing and ICD database, PO Box 9205, Bridge of Weir, Strathclyde PA11 3AZ, telephone 01505 612 829.
All clinicians and cardiac technicians managing patients implanted with GEM® DR 7271 or Micro Jewel® II 7223Cx implantable cardioverter defibrillators.
NHS Trusts (England) - Chief Executives Healthcare Commission (CHAI) - Headquarters
via CE Bulletin
Please bring this notice to the attention of all who need to know or be aware of it. This will include distribution by:
- Liaison officers (for onward distribution)
- Cardiac pacemaker/ICD technicians
- Cardiologists in pacing and electrophysiology
- Clinical governance leads
- Health & safety officers
- Medical directors
HEALTHCARE COMMISSION (CHAI) to:
- Headquarters (for onward distribution)
- Hospitals in the independent sector
Enquiries to the manufacturer should be addressed to:
David G Dunham BSc PhD, Regulatory Affairs Manager - UK & Ireland, Cardiac Rhythm Management, Medtronic (UK) Ltd, Suite One, Sherbourne House, Croxley Business Centre, Watford, WD18 8WW
Tel: 01923 212 213
Enquiries to the MHRA should quote reference number 20030701.009-7 and be addressed to:
Mr Peter Solesbury or Miss Anna Richter, Medicines & Healthcare products Regulatory Agency, Hannibal House, Elephant and Castle, London SE1 6TQ
Tel: 020 7972 8215 / 8223Fax: 020 7972 8106
Dr Jon Hopper, Medicines & Healthcare products Regulatory Agency, Hannibal House, Elephant and Castle, London SE1 6TQ
Tel: 020 7972 8126Fax: 020 7972 8111
APPENDIX 1 to MDA/2004/045 - Medtronic’s Advisory Notice
Medtronic LimitedSuite OneSherbourne HouseCroxley Business CentreWatford, Herts WD18 8WWTelephone: 01923 212213Facsimile: 01923 241004
7th April 2004
IMPORTANT PATIENT SAFETY INFORMATION
Medtronic is providing an update to previous advisory notices for GEM® DR Model 7271 and Micro Jewel® II Model 7223Cx ICDs. This update replaces recommendations made for the GEM DR Model 7271 in December 1999, and for the Micro Jewel Model 7223Cx provided in August 1999 and November 2000 about suspect capacitors in identified populations. This notification is consistent with our commitment to provide you with ongoing performance updated.
Because of the concern that these ICDs with suspect capacitors may not be consistently capable of providing high voltage energy delifery near or at ERI (4.91 V) and continuing through EOL (4.57 V), we are issuing the following revised recommendations:
If the patient’s last follow-up was within the previous three months, and records are available, verify the recorded battery voltage and capacitor charge time as below.
For all others, schedule follow-up as soon as possible, and verify the charge time and battery voltages below.
Schedule replacement for any device with:
battery voltage of5.16 V or less,(NEW RECOMMENDATION)
OR charge time of18 seconds or greater.
If the battery voltage is greater than 5.16 volts, verify the charge time:
If less than 18 seconds but greater than 14 seconds, program the Automatic Capacitor Formation Interval to one month.
No additional reporgramming is required if verified charge time is less than 14 seconds, or if capacitor formation is already set to one month.
Continue to follow these patients at least at three monthly intervals.
These recommendations relate only to the Micro Jewel II and Gem DR ICDs identified by serial number on the attached list. No other Micro Jewel II Model 7223Cx or GEM DR Model 7271 devices are affected.
This update supercedes earlier Micro Jewel II letters (August 1999 and November 2000) and a GEM DR letter (December 1999) regarding the same previously identified population of devices with capacitors from specific component lots. Those communications focused on managing performance of affected devices throught the Automatic Capacitor Formation Interval and replacing devices with charge times of 18 seconds or greater.
Worldwide, we have now seen thirty (30) Micro Jewel II devices with suspect capacitors that hve experience unexpected performance of the charge circuit at vattery voltages near ERI. Six (6) of these occurred during cardiac arrhythmias, resulting in therapy not being delivered.
Although all field reports to date have involved Micro Jewel II devices, it is possible that some GEM DR devices with suspect capacitors could exhibit similar behavior. Therefore, this recommendation applies to both Micro Jewel II (~1386 active units worldwide) and GEM DR (~435 active units worldwide) with suspect capacitors. These devices were implanted in 1997 and 1998.
We sincerely apologise for any inconvenience this has caused to you and your patients. If you have questions, or would like information about our supplemental warranty for these devices, please contact your Medtronic Sales Representative or myself at the Medtronic UK Office on 01923 212213.
The Medicines and Healthcare products Regulatory Agency (MHRA) have been consulted in respect to this notification.
David G. Dunham BSc (Hon). PhDClinical, Technical & Education ManagerCardiac Rhythm Management
Affected serial numbers are in the attached PDF file.