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

Model Number CD1357-40Q

Device Problems Failure to Capture (1081); Failure to Deliver Shock/Stimulation (1133); Low impedance (2285); Battery Problem (2885)

Patient Problem Ventricular Tachycardia (2132)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.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

Related manufacturer reference number: 2017865-2020-16833.Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and the device was explanted.Patient was stable after the procedure.It was also noted that patient had a ventricular tachycardia episode that required external defibrillation due to shock therapy being disabled.The bpa also caused loss of capture and low out of range pacing and defibrillation impedance for the right ventricular lead.Physician also saw that the patient's right ventricular lead's suture sleeve was no longer in place during the bpa generator change procedure.Lead had normal measurements and was connected to new device.

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 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
• MDR Report Key: 10758936
• MDR Text Key: 213841292
• Report Number: 2017865-2020-16832
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734507974
• UDI-Public: 05414734507974
• 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
• Report Date: 12/16/2020

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: 08/31/2016
• Device Model Number: CD1357-40Q
• Device Catalogue Number: CD1357-40Q
• Device Lot Number: 4765486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0115-2017
• Patient Sequence Number: 1
• Treatment: DURATA STS LEAD; DURATA STS LEAD
• Patient Outcome(s): Required Intervention