Medtronic Maximo II CRT-D, model D284TRK. Digital implantable cardioverter defibrillator with cardiac resynchronization

FDA device recall Z-0112-2011 · posted 2010-10-21 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Managment

Reason for recall

Medtronic is informing you of a rare device software issue in certain ICD and CRT-D devices. A software update will be available to correct his issue. There have been 5 reports of this issue occurring with no reported patient injuries or deaths. Medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. In the u

Action taken

Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected. For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.

Root cause

Software design

Status

Terminated

Product code

NIK

Quantity affected

16910

Distribution

Worldwide Distribution - USA, Puerto Rico, Virgin Islands, and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia,

Date initiated

2010-05-05

Date posted

2010-10-21

Date terminated

2012-03-15

Location

Saint Paul, MN