A safety communication was just added to the FDA Medical Device Safety webpage.
TOPIC: Medtronic Pacemakers: Safety Communication – Due to Premature Battery Depletion
AUDIENCE: Cardiology, Patient, Health Professional, Surgery
ISSUE: FDA is issuing this safety communication to alert health professionals and patients about issues that may cause batteries in certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) to drain more quickly than expected without warning patients or health care providers.
Affected Medtronic implantable pacemaker and CRT-P device models include:
- Azure models: W1DR01, W2DR01, W3DR01, W1SR01, W2SR01, W3SR01
- Astra models: X1DR01, X2DR01, X3DR01, X1SR01, X2SR01, X3SR01
- Percepta models: W1TR01, W1TR04, W4TR01, W4TR04
- Serena models: W1TR02, W1TR05, W4TR02, W4TR05
- Solara models: W1TR03, W1TR06, W4TR03, W4TR06