Device product
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Z-2825-2018
Product summary
- Firm
- Sorin CRM SAS
- Event
- Event 80636
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-2825-2018
Official wording
Reason: Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.
Code information: Model TDF037U, UDI GTIN 08031527015484 Serial Numbers: 637DC0D0, 637DC13F, 625DC128, 622DC17A, 620DC034, 627DC0E0, 619DC101, 620DC07F, 622DC02C, 619DC0E1
Distribution pattern: US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS
Derived failure modes
-
Unknown
Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.