Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN… recallZ-3233-2017 · Sorin Group Italia SRL - CRF · initiated Jul 24, 2017

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number

Z-3233-2017

Recall class

Class II

Status

Terminated

Initiated by the company

Jul 24, 2017

Posted by the FDA

Sep 28, 2017

Recalling firm

Sorin Group Italia SRL - CRF

Quantity

68 units

Product code

NIK

FDA submissions

P060027

Distribution

US Nationwide Distribution

Product description

Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, 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).

Other devices under the same FDA submission

3 devices cleared under P060027 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• PLATINIUM CRT-D 1711

  Microport Crm Srl · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall5 reports
• PLATINIUM CRT-D 1741

  Microport Crm Srl · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall4 reports
• Paradym RF CRT-D 9750

  Microport Crm Srl · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 77983).

• Z-3228-2017 · Terminated
  Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single cham…
• Z-3229-2017 · Terminated
  Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single cham…
• Z-3230-2017 · Terminated
  Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single…
• Z-3231-2017 · Terminated
  Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single …
• Z-3232-2017 · Terminated
  Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single …