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

Model Number CD1231-40Q

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332)

Patient Problems Death (1802); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

Event Type  Death  

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.

Event Description

It was reported that a patient presented with an implantable cardioverter defibrillator could not be interrogated.Multiple programmers and wands were used in different locations and distances to no avail.A couple days later, the patient expired.It was unknown if the telemetry issue or any other issue involving the device or implanted lead was responsible for the patient's death.Related manufacturer reference number: 2017865-2021-00018.

Manufacturer Narrative

Communication failure and premature battery depletion were confirmed by analysis.A device evaluation was performed, and 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.

Manufacturer Narrative

Communication failure and premature battery depletion were confirmed by analysis.A longevity calculation was performed based upon programmed settings and usage data up to end of service (eos) timestamp.The calculations showed the battery depleted prematurely.The cause of premature battery depletion could not be conclusively determined.

Event Description

New information notes that patient's history of ventricular tachycardia storms that were addressed with therapies could have contributed to rapid battery depletion that led to loss of telemetry.

Manufacturer Narrative

The reported field event of communication failure was confirmed by analysis.The cause of communication failure was due to low battery voltage.A longevity calculation was performed based upon programmed settings and usage data up to end of service (eos) timestamp.The calculations showed the device did not meet its overall expected longevity requirements.In an effort to isolate the root-cause, extensive bench testing was performed; in the lab and by the battery manufacturer.The battery analysis by the manufacturer indicated three clusters were found in the cell.None of the clusters were in a location that could have resulted in premature battery depletion.No sources of high current drain on the hybrid were noted.Device¿s functionality was tested; pacing, sensing, impedance, high voltage output, and patient notifier were tested and no anomaly was detected.No component anomalies or malfunctions that would account for premature battery depletion were identified in the device.As per the follow-up communication with the field, it was indicated that the patient had a history of multiple ventricular tachycardia (vt) events and high voltage therapies.It is quite possible that the patient had on-going arrhythmia and received appropriate therapies during october (b)(6) 2020, which would then have exhausted the battery normally.However, since the device image and/sessions during this timeframe were not available, the cause of the rapid battery depletion could not be conclusively determined.

• 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: 11105650
• MDR Text Key: 224732055
• Report Number: 2017865-2021-00017
• 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,Followup
• Report Date: 07/13/2021

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: 02/28/2013
• Device Model Number: CD1231-40Q
• Device Catalogue Number: CD1231-40Q
• Device Lot Number: 3472889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/03/2021
• Supplement Dates Manufacturer Received: 03/01/2021; 05/18/2021; 07/09/2021
• Supplement Dates FDA Received: 03/21/2021; 06/11/2021; 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0115-2017
• Patient Sequence Number: 1
• Treatment: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 107