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

Model Number CD3371-40QC

Device Problem Delayed Charge Time (2586)

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

Event Date 05/13/2020

Event Type  Injury  

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 during a clinic follow-up the implantable cardioverter defibrillator exhibited long charge time due to capacitor issue.The device was explanted and replaced.The patient was stable.

Manufacturer Narrative

The reported field event of extended charge time was not confirmed in the lab.Device data recorded normal charge times for all capm's performed during the event.The device was above the elective replacement indicator (eri) when received.Telemetry, pacing, sensing, impedance, hv output and patient notifier were tested on the bench; no anomaly was detected.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10111096
• MDR Text Key: 193396660
• Report Number: 2938836-2020-06578
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

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: 02/29/2016
• Device Model Number: CD3371-40QC
• Device Lot Number: 4589165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 95