MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA ICD; NO MATCH

Model Number CD3367-40QC

Device Problems Loose or Intermittent Connection (1371); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  malfunction  

Event Description

Related manufacturer report number: 2017865-2024-00245.It was reported that the right ventricular (rv) lead was difficult to attach to the device as the set screw was difficult to tighten during the implant procedure.After successfully fastening the lead to the header, the insulation of the rv lead appeared to be detached from the rest of the lead.An attempt was made to remove the rv lead from the header, however, it was unable to be removed.The set screw was retracted again and the rv lead was successfully removed.The rv lead and device were explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported field event of set screw anomaly was confirmed and the event of difficult to remove was not confirmed.Septum material was observed inside the right ventricular set screw hex cavity and the set screw was stripped.As a result, this did not allow the set screw to be tightened and secured properly in the field.The issue was consistent with having occurred during the procedure.The device was above elective replacement indicator (eri) voltage level when received.The telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and observed to be normal.

• Brand Name: QUADRA ASSURA ICD
• Type of Device: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18436998
• MDR Text Key: 331816288
• Report Number: 2017865-2024-00246
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: CD3367-40QC
• Device Lot Number: A000120142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• 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