Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator, Biventricular

FDA device recall Z-3229-2017 · posted 2017-09-28 · Terminated

Recall details

Recalling firm

Sorin Group Italia SRL - CRF

Reason for recall

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.

Action taken

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; " It is recommended that a routine follow-up examination be done one month after discharge, and then every three months until the device nears the replacement date.

Root cause

Software design

Status

Terminated

Product code

MRM

Quantity affected

206 units

Distribution

US Nationwide Distribution

Date initiated

2017-07-24

Date posted

2017-09-28

Date terminated

2024-01-29

Location

Saluggia VC, Italy