MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 DF1 US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD1231-40

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Patient Involvement (2645)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.Premature battery depletion was confirmed by analysis.No sources of high current were noted.The cause of the premature battery depletion was consistent with lithium (li) cluster formation.From these analyses, in the absence of high current draw, it is probable that the premature battery depletion was caused by a lithium cluster induced short circuit.Li clusters are a known depletion mechanism for these advisory products that has been investigated and associated with a field action in october 2016.

Event Description

This report is to advise of an event observed during analysis.The implantable cardioverter defibrillator exhibited premature battery depletion and a battery performance alert.

• Brand Name: FORTIFY VR, U1.6 DF1 US
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 11382685
• MDR Text Key: 233741993
• Report Number: 2017865-2021-09534
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504355
• UDI-Public: 05414734504355
• Combination Product (y/n): N
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Model Number: CD1231-40
• Device Catalogue Number: CD1231-40
• Device Lot Number: 3123340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0003-2018;Z-0115-2017
• Patient Sequence Number: 1