Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system

FDA device recall Z-1440-2010 · posted 2010-04-26 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Managment

Reason for recall

Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. If the software update referenced above is not implemented, there will be a potential risk of loss of device functionality or risk for loss of therapy at or near ERI in a small number of devices. The software will eliminate this issue, fo

Action taken

Consignees were given a Medtronic "Important : Medical Device Correction" letter addressed to "Dear Doctor" and dated February 2010. In the letter, Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. The letter included recommendations including that Medtronic recommends physicians continue to use the ERI notification to determine time for device replacement. At this time, no other action, reprogramming or change in the frequency of follow-up is recommended. For additional information or assistance, please contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DXY

Quantity affected

approximately 120,061 worldwide

Distribution

All States in the USA including Guam, Puerto Rico and DC. OUS: Customers in the following countries: Andorra, Argentina, Aruba, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Brunei, Daruss

Date initiated

2010-02-11

Date posted

2010-04-26

Date terminated

2013-01-08

Location

Saint Paul, MN