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U.S. Department of Health and Human Services

Class 2 Device Recall Platinium DR DF4 1540

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  Class 2 Device Recall Platinium DR DF4 1540 see related information
Date Initiated by Firm July 24, 2017
Date Posted September 28, 2017
Recall Status1 Terminated 3 on January 29, 2024
Recall Number Z-3232-2017
Recall Event ID 77983
PMA Number P980049 
Product Classification Defibrillator, implantable, dual-chamber - Product Code MRM
Product Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, 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).
Code Information All Serial Numbers
Recalling Firm/
Manufacturer		 Sorin Group Italia SRL - CRF
Via Crescentino
Saluggia, VC Italy
Manufacturer Reason
for Recall		 There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac ResynchronizationTherapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.
FDA Determined
Cause 2		 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; " 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.
Quantity in Commerce 86 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MRM and Original Applicant = MicroPort CRM USA Inc.
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