Recall Z-3231-2017 ยท MRM Defibrillator, Implantable, Dual-Chamber
Sorin Group Italia SRL - CRF
Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the follow
| Date | Sep 28, 2017 (initiated Jul 24, 2017) |
| Status | Terminated |
| Reason | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take. |
| Root cause | Software design |
| Action | LivaNova issued a communication to physicians treating patients implanted with the products in scope in the form of a customer letter beginning July 24, 2017. The letter instructs users to do the following: 1. In order to mitigate the potential risks associated with both triggering events (ESD at implant or MRI scan), LivaNova recommends physicians follow the patients at the periodicity already stated in the implant manual, especially: " Before the patient is discharged and at each subsequent follow-up, it is advisable to check the battery status and the occurrence of system warnings; |
| Quantity | 72 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.