URGENT MEDICAL DEVICE RECALL

For a Subset of Medtronic Dual Chamber Pacemakers

January 2019

Dear Physician or Healthcare Professional,

This letter is to inform you of a voluntary recall and distribution suspension affecting a subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta™, Versa™ and Sensia™. Please note that not all devices within these brand names are affected by this recall. This letter contains a description of the issue and programming recommendations.

Devices in the affected subset, when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality. See Table 1 for modes that are susceptible to this circuit error. For this error to occur, a unique combination of events must take place while the device is processing an atrial-sensed event. If this error occurs, the device will be unable to provide pacing until a ventricular-sensed event (VS) is detected. Once a VS is detected, normal pacing functionality is restored immediately. If a VS is not detected, the device will withhold both atrial and ventricular pacing. In addition, until a VS is detected, the device will be unable to initiate a session with a programmer, initiate a session with a CareLink™ remote monitor, or respond to a magnet. Single chamber and dual chamber pacing modes that do not sense atrial activity are not susceptible to this circuit error (see Table 1).

Table 1: Identification of modes susceptible/not susceptible to circuit error
Modes susceptible to circuit error Modes NOT susceptible to circuit error

DDD, DDDR
DDI, DDIR
VDD
ADI, ADIR
VDI, VDIR
ODO
OAO
MVP — when operating in DDD, DDDR, DDI or DDIR mode

VVI, VVIR
DVI, DVIR
AAI, AAIR
VOO, VOOR
AOO, AOOR
DOO, DOOR
OVO
VVT, AAT

Through 4 January 2019, Medtronic is aware of four (4) reported occurrences in two (2) patients where a pause in pacing therapy was clinically apparent due to this circuit error. These reported events occurred in three (3) devices from a total of 156,957 devices sold worldwide. No deaths have been reported as a result of this issue.

Patient risk is determined by the patient’s underlying cardiac rhythm and whether the device is in a susceptible pacing mode as described above. Through our analysis of this issue, Medtronic estimates that on average, a device in a susceptible pacing mode has a 2.8% chance per month of experiencing a pacing pause of 1.5 seconds or longer. Risk is minimized in patients who have an escape rhythm adequate to prevent syncope during a loss of ventricular pacing, since a VS restores full device functionality. No risk of a pause due to this circuit error exists for patients programmed to a non-susceptible pacing mode.

The root cause for this issue is related to a design change to an integrated circuit in a subset of devices that were distributed between 10 March 2017 and 7 January 2019.

Medtronic is developing a software update that can be installed into affected devices to correct this issue. Medtronic estimates submission of this software update to regulatory agencies by the 2nd half of 2019. Upon subsequent regulatory approval, Medtronic will notify customers of its availability. Until that time, Medtronic is providing the patient management recommendations described below and depicted in Appendix A.

Medtronic records indicate you are following one or more patients with an affected device, as noted in the enclosed Physician/Patient Detail Report. Additionally, patients and clinicians may determine if a specific device is affected by looking up the serial number on Medtronic’s Product Performance website: http://wwwp.medtronic.com/productperformance/

Medtronic records indicate that your facility may have product inventory potentially affected by this issue. As a result, Medtronic requests that you immediately take the following actions:

  1. Segregate and remove all unused affected product from your inventory.
  2. Return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at 1‑800‑848‑9300 to initiate a product return and credit. Your local Medtronic Representative can assist you in product return and replacement as necessary.

Patient Management Recommendations

We realize that each patient requires unique clinical considerations. In consultation with Medtronic’s Independent Physician Quality Panel (IPQP), Medtronic recommends programming to a non-susceptible pacing mode as the primary mitigation for patients implanted with an affected device until the software update has been installed. Specific patient risk assessment and programming recommendations are outlined below and provided in Appendix A.

  • For patients whose device is programmed to a non-susceptible mode (see Table 1), no action is needed at this time. Continue routine clinical monitoring.
  • For patients whose device is programmed to a susceptible mode and are continually in persistent atrial fibrillation, reprogramming the device to the non-susceptible VVI or VVIR mode is recommended to eliminate risk due to this issue until the software update has been installed. Continue routine clinical monitoring.
  • For patients whose device is programmed to a susceptible mode and either: have no underlying ventricular escape rhythm; or are at risk for a symptomatic pause until a ventricular escape beat occurs, programming to a non-susceptible mode is recommended to eliminate risk due to this issue until the software update has been installed. Continue routine clinical monitoring.
  • For patients who do not tolerate programming to a non-susceptible pacing mode and either: have no underlying ventricular escape rhythm; or are at risk for a symptomatic pause until a ventricular escape beat occurs, continue clinical monitoring in a susceptible mode until the software update is available, or consider device replacement.
    • The estimated per patient mortality risk due to this issue is 0.021% when programmed to a susceptible pacing mode over the estimated time until the software update becomes available. This risk is comparable to the Medtronic estimated per-patient mortality risk associated with a device replacement (0.027%).*
    • If a patient reports symptoms consistent with a pacing pause, and you would like assistance assessing whether a patient had a pause due to this issue, contact your Medtronic representative.
  • Advise patients remaining in a susceptible mode to seek immediate medical attention if they experience new or unexpected symptoms consistent with a pacing pause.
  • Other than reprogramming to a non-susceptible pacing mode, no additional programming options have been identified to mitigate this issue.

Medtronic will notify all applicable regulatory agencies about this matter. Please share this notification with others in your organization as appropriate.

As always, please notify Medtronic of any adverse events or quality problems associated with your use of this product. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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, option 1, then option 3 (Monday–Friday, 8am–5pm Central Time). If you have any questions, please contact your local Medtronic Representative or Medtronic Technical Services at 800‑505‑4636.

Sincerely,

Chris Harrold
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm and Heart Failure

*

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

Appendix A: Programming decision flow chart

Programming decision flow chart