Device Recall Platinium VR 1210 의 리콜

Recall

77983

Class 2

Z-3228-2017

2017-07-24

2017-09-28

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158438

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.

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.