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

Model Number CD3367-40C

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); No Device Output (1435); Appropriate Term/Code Not Available (3191)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Manufacturer Narrative

No code available for loss of magnet response and loss of patient notifier.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 the patient presented in clinic for a routine follow-up check.During the check, the patient¿s implantable cardioverter defibrillator could not be interrogated.An electrocardiogram trace revealed native qrs patterns with no evidence of pacing.A magnet was placed over the device which had no effect.Premature depletion of the device was suspected.The patient did not receive any patient notifiers.The patient reported experiencing increased shortness of breath over the last couple of weeks.The patient was admitted.On (b)(6) 2018, the patient¿s device was removed and replaced.The procedure was completed without complication.

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 (b)(6) 2016.

• Brand Name: QUADRA ASSURA ICD
• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8024366
• MDR Text Key: 125659718
• Report Number: 2017865-2018-16261
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: CD3367-40C
• Device Lot Number: 4222812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2013
• 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-0117-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR