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

Model Number CD3371-40QC

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

Patient Problem Bradycardia (1751)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

The product was not returned and a comprehensive device investigation could not be performed.

Event Description

It was reported that the patient presented in-clinic for a routine device check and their cardiac defibrillator could not be interrogated.The patient was experiencing bradycardia due to the device not delivering bi-ventricular pacing.The loss of bi-ventricular pacing was suspected to be due to premature battery depletion.A device replacement procedure was scheduled and successfully performed.The patient was stable with no adverse consequences before, during and after the procedure.

Manufacturer Narrative

Final analysis revealed that the reported field event of failure to interrogate was not confirmed in the laboratory.The device was tested on the bench and no anomalies were found.

Manufacturer Narrative

Correction: final analysis revealed that the reported field events of premature battery depletion, loss of pacing, and failure to interrogate were not confirmed in the laboratory.The device was tested on the bench and no anomalies.

Manufacturer Narrative

Correction: this supplemental report is to address an amendment to the previously reported device analysis.Results and conclusion codes updated to reflect new information.Final analysis found the reported events of failure to interrogate and premature battery depletion were confirmed in the laboratory.High current was observed during bench testing and was traced to the hybrid.The cause of the premature battery depletion was due to excess current on the hybrid.

• Brand Name: QUADRA ASSURA MP 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: 6812130
• MDR Text Key: 83293579
• Report Number: 2017865-2017-08354
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/01/2018

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: 09/30/2015
• Device Model Number: CD3371-40QC
• Device Catalogue Number: CD3371-40QC
• Device Lot Number: 4267284
• Other Device ID Number: 05414734508407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 08/22/2017
• Supplement Dates Manufacturer Received: 07/17/2018; 07/17/2018; 09/14/2018
• Supplement Dates FDA Received: 07/31/2018; 08/05/2018; 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention