MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3357-40Q

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); No Device Output (1435)

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

Event Date 08/29/2017

Event Type  Injury  

Event Description

It was reported that the patient presented in-clinic on (b)(6) 2017 after feeling what he thought was a vibratory alert.The implantable cardioverter defibrillator was not able to be interrogated.An electrocardiogram was performed and showed a complete loss of output.Premature battery depletion was suspected.The device was explanted and replaced.The patient was stable 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 october 2016.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6880169
• MDR Text Key: 86770805
• Report Number: 2017865-2017-32062
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: CD3357-40Q
• Device Catalogue Number: CD3357-40Q
• Device Lot Number: 4341802
• Other Device ID Number: 05414734508216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2013
• 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-0116-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR