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

Model Number CD2357-40C

Device Problems Defective Alarm (1014); Premature Discharge of Battery (1057); Failure to Interrogate (1332); Battery Problem (2885)

Patient Problems Arrhythmia (1721); Fatigue (1849)

Event Date 03/24/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient presented in clinic with a complaint of lack of energy.Patient slow heart rate was observed.The device was unable to be interrogated.No vibration notifier was also noted.Premature battery depletion was suspected.The device was explanted and replaced.No patient issues were noted after the procedure.The patient was discharged.

Event Description

New information received notes that battery performance alert (bpa) advisory was received.

Manufacturer Narrative

Communication failure and premature battery depletion were confirmed by analysis.No sources of high current were noted.The cause of the premature battery depletion was consistent with 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.

• Brand Name: FORTIFY ASSURA DR ICD, US
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9945372
• MDR Text Key: 187113717
• Report Number: 2938836-2020-02574
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508063
• UDI-Public: 05414734508063
• 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: 06/16/2020

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: 05/31/2016
• Device Model Number: CD2357-40C
• Device Catalogue Number: CD2357-40C
• Device Lot Number: 4607552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 04/07/2020; 06/08/2020
• Supplement Dates FDA Received: 04/23/2020; 06/16/2020
• 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