URGENT MEDICAL DEVICE RECALL

For a Subset of Medtronic
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and
Implantable Cardioverter Defibrillators (ICDs)

Model Listing in Appendix A

March 2018,

Dear Physician or Healthcare Professional,

This letter is to inform you of a voluntary recall affecting 752 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs) (see Appendix A) that may have undergone a specific sequence of manufacturing processes that could lead to an out-of-specification internal gas environment. This may introduce a risk for internal arcing during high-voltage charging, resulting in immediate and permanent loss of device functionality, including pacing and high-voltage therapy. This specific manufacturing sequence is no longer performed. There have been no patient injuries or deaths reported in this advisory population.

Medtronic records indicate you are following one or more patients implanted with an affected device as noted in the enclosed Physician / Patient Detail Report. Visit http://wwwp.medtronic.com/productperformance/advisories.html  for a complete list of model and serial numbers for the identified population.

Background:
In January 2018, Medtronic completed notification to physicians following 48 patients implanted with a device at risk for failure due to the issue described above (referred to as the Higher-Risk Subset). Within this subset, if the device delivered the maximum number of shocks until battery depletion, we communicated that 23% of these devices would experience arcing during high voltage charging, with failure occurring within the first two (2) high-voltage charges in 7.7% of the devices.

Current Advisory:
Concurrent with the analysis that identified the Higher-Risk Subset of devices, we continued to evaluate additional devices and identified 752 devices at lower risk (referred to as the Lower-Risk Subset).  A comprehensive engineering evaluation and review of ICD and CRT-D manufacturing records has now been completed and all devices that may have gone through this manufacturing sequence have been identified.

Within this Lower-Risk Subset of 752 devices, if the device delivered the maximum number of shocks until battery depletion, we estimate 0.5% of these devices would experience arcing during high voltage charging, with failure occurring within the first two (2) high-voltage charges in 0.18% of the devices. See table below for comparison of device subsets.

Through 8 March 2018, there have been zero (0) complaints related to internal arcing in these 752 devices.  While the risk for failure is lower in this group of devices, it is not possible to identify which of these 752 devices may fail or when they may fail.  Successful delivery of previous high-voltage therapy does not ensure future performance.  

Table – Device Subsets

Patient Management Recommendations
We realize that each patient requires unique clinical considerations. In consultation with Medtronic’s Independent Physician Quality Panel (IPQP), Medtronic provides the following recommendations to physicians for patients who have been implanted with one of the identified devices:

• Prophylactic device replacement should be considered for patients at higher risk, including patients whose clinical history indicates prior need for high-voltage therapy and/or for pacemaker-dependent patients.
• Physicians should carefully weigh the risks and benefits of device replacement. The estimated per patient risk for mortality due to this issue is 0.02% to 0.04% considering the risk of device failure and the likelihood of a patient requiring high voltage therapy. This is comparable to the estimated per patient mortality risk of complications associated with a device replacement (0.04%) .^{i, ii}
• For patients in whom it is determined that replacement is not warranted:
  • Consider programming changes to reduce the potential for high-voltage charges associated with arrhythmia detection and therapies, such as enabling ATP before charging for fast ventricular rhythms or programming a separate fast VT via VF zone with ATP. For assistance with patient-specific programming needs, contact Medtronic Technical Services at 800-723-4636.
  • Continue three-month in-clinic or remote follow-ups to verify device functionality. Inability to interrogate a device or a failed remote monitoring transmission may be an indication that internal arcing has occurred. Devices that have failed will not send an alert as telemetry and all device functionality is immediately lost if internal arcing occurs. 
    
  • Advise patients to seek medical attention immediately if they experience new or unexpected symptoms suspicious for a ventricular arrhythmia.

Medtronic will offer a supplemental device warranty for prophylactic replacements in this affected population. Contact your Medtronic sales representative for terms and conditions. Medtronic will notify all applicable regulatory agencies about this matter.  Please share this notification with others in your organization as appropriate.

We sincerely regret any difficulties this may cause you and your patients. Medtronic remains dedicated to patient safety and will continue to monitor device performance to ensure we meet your needs and those of your patients. Medtronic Patient Services is available to assist patients at 800-551-5544 (Monday-Friday, 8am-5pm Central Time). If you have any questions, please contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
  
  

Sincerely,

Tim Samsel
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Heart Failure

ⁱ Medtronic Data on File. MDT2260884-CRHF CIED Infection Report; MRCS: MDT2260884, Version 2.0, 11/02/2015.

ⁱⁱ Birnie, D et al. Complications associated with defibrillation threshold testing: The Canadian experience. Heart Rhythm, Volume 5, Issue 3, Pages 387-390.

Appendix A: Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs) Model Listing