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

Model Number CD1357-40Q

Device Problems Premature Discharge of Battery (1057); Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2022

Event Type  Injury  

Event Description

It was reported that following the battery performance alert (bpa) advisory, a bpa was received by the clinician on (b)(6) 2022.The patient was seen in clinic on (b)(6) 2023 and the battery had reset and was predicting 2.1 years of remaining longevity with battery current 12ua and charge time 9.5 sec.The device was explanted and replaced.The patient was stable.

Manufacturer Narrative

Premature battery depletion was confirmed by analysis.A device evaluation was performed, and no sources of high currents were noted.The cause of the premature battery depletion was consistent with li cluster formation.From these analyses, in the absence of a high current draw, it is probable that a lithium cluster-induced short circuit caused premature battery depletion.Li clusters are a known depletion mechanism for these advisory products that have been investigated and associated with a field action in october 2016.

• Brand Name: FORTIFY ASSURA VR ICD, 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16506964
• MDR Text Key: 310948408
• Report Number: 2017865-2023-13206
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734507974
• UDI-Public: 05414734507974
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

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: 05/31/2016
• Device Model Number: CD1357-40Q
• Device Catalogue Number: CD1357-40Q
• Device Lot Number: 4623292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2014
• 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
• Treatment: DURATA ACTIVE LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female