MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 SJ4 US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD1231-40Q

Device Problem Telemetry Discrepancy (1629)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Further information was requested but not received.

Event Description

It was reported that the implantable cardioverter defibrillator (icd) exhibited difficulty transmitting data.The patient was sent an inductive transmitter and was having difficulty pairing it with his device.No intervention was reported.The patient remained in stable condition.

Event Description

New information received notes that the device was explanted and replaced with a bi-ventricular device on (b)(6) 2020.The patient was in stable condition before, during and post procedure.

Manufacturer Narrative

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 (b)(6) 2016.

• Brand Name: FORTIFY VR, U1.6 SJ4 US
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10276546
• MDR Text Key: 198893699
• Report Number: 2017865-2020-09129
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504348
• UDI-Public: 05414734504348
• Combination Product (y/n): N
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Model Number: CD1231-40Q
• Device Catalogue Number: CD1231-40Q
• Device Lot Number: 3432240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 07/16/2020; 09/14/2020
• Supplement Dates FDA Received: 07/31/2020; 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0115-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR