MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3367-40C

Device Problem Component Missing (2306)

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

Event Date 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

During initial implant procedure, the set screw was missing from the device header.The device was explanted and replaced to resolve the event.The patient was stable with no consequences.

Manufacturer Narrative

The reported field event of setscrew issue was verified in the lab.The left ventricular is4 setscrew was found to be completely backed out from its connector block as a result of unscrewing the setscrew too far.The is4 setscrew inset was also found to have been slightly stripped and septum debris was lodged inside the hex cavity.The setscrew was re-engaged with the connector block and operated normally in affixing a test lead to the device.Interrogation of the device revealed the device was above elective replacement indicator (eri) when received.No anomaly was detected.

• Brand Name: QUADRA ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10063613
• MDR Text Key: 191192448
• Report Number: 2938836-2020-03175
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: CD3367-40C
• Device Lot Number: P000087688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 06/16/2020
• Supplement Dates FDA Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1