Events

Recall of Device Recall Platinium VR DF4 1240

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorin Group Italia SRL - CRF.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77983
  • Event Risk Class
    Class 2
  • Event Number
    Z-3231-2017
  • Event Initiated Date
    2017-07-24
  • Event Date Posted
    2017-09-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158442
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Defibrillator, implantable, dual-chamber - Product Code MRM
  • 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.
  • 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; " 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.

Device

Device Recall Platinium VR DF4 1240
  • Model / Serial
    All Serial Numbers
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    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 following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
  • Manufacturer
    Sorin Group Italia SRL - CRF

Manufacturer

Sorin Group Italia SRL - CRF
  • Manufacturer Address
    Sorin Group Italia SRL - CRF, Via Crescentino, Saluggia, VC Italy
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA