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

Model Number CD3371-40QC

Device Problem Fitting Problem (2183)

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

Event Date 01/17/2020

Event Type  malfunction  

Event Description

During a unrelated lead revision procedure, there was a connection issues between the header of the device and the lead.The device was explanted and replaced to resolve the event and the patient was in stable condition throughout the event.

Manufacturer Narrative

The reported field event of set screw anomaly was verified in the lab.The df4 and the is-1 set screws were found to be completely backed out from the set screw threads as a result of unscrewing the set screws too far.When the screws were re-engaged with the connector block, the screw operated normally in affixing a test lead to the device.The issue was consistent with the procedure.Interrogation of the device revealed the device was above elective replacement indicator (eri) when received.The device pacing lead impedances and sensing were tested on the bench and they were found to be normal.

Event Description

During a unrelated lead revision procedure, the atrial lead was unable to be connected to the device due to a set screw anomaly.The device was explanted and replaced to resolve the event and the patient was in stable condition throughout the event.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9652877
• MDR Text Key: 177193505
• Report Number: 2938836-2020-00759
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 05/05/2020

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: 07/31/2021
• Device Model Number: CD3371-40QC
• Device Lot Number: P000085413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 01/31/2020
• Supplement Dates Manufacturer Received: 05/01/2020
• Supplement Dates FDA Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2019
• 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