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

Model Number CD3371-40Q

Device Problem Failure to Disconnect (2541)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

Event Type  malfunction  

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

During device replacement due to normal eri, the left ventricular (lv) lead was unable to be removed from the device header.The set screw was unable to be loosened.Upon lv lead removal attempt the lead broke, and pin remained in the header.The event was resolved by explanting and replacing the lv lead, and device due to normal eri.The patient was in stable condition.Related to manufacturer report number: 2017865-2020-23111.

Manufacturer Narrative

The reported event of failure to disconnect was confirmed in the lab.Interrogation of the device revealed the device was at the elective replacement indicator when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Pacing, sensing, impedance, hv output, patient notifier was tested and no anomaly was detected.A partial lead was stuck in the lv bore of the device.This partial lead was unable to be removed due to the lvtip set screw being stripped.Remains of septum material was found in the lvtip set screw hex cavity.The septum material in the hex cavity prevented full insertion of the torque driver and was the cause of the field event.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 11037173
• MDR Text Key: 222345405
• Report Number: 2938836-2020-09761
• 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: 02/09/2021

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: 07/31/2015
• Device Model Number: CD3371-40Q
• Device Lot Number: 4219622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUARTET; QUARTET