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

Model Number CD3367-40C

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 08/31/2023

Event Type  malfunction  

Event Description

During a revision procedure for a non-abbott product, while attempting to connect the new lead it was not possible to tighten the set screw on the header of the device.A new device was implanted to resolve the event.The patient was stable and there were no consequences.

Manufacturer Narrative

The reported field event of lead connection issue was verified in lab.However, the issue was consistent with having occurred during the procedure.The svc (df1) set screw was missing when the device was received.The device manufacturing history record was reviewed and showed no anomaly prior to its distribution.It is believed that the svc set screw fell out during the procedure.Septum material was observed inside the rv set screw hex cavity.This did not allow the set screw to be tightened and secured properly in the field.The device was tested on the bench using test set screw and leads; the test leads were fully inserted and secured properly.Interrogation of the device revealed the device was above elective replacement indicator (eri) upon receipt.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found 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: 17839745
• MDR Text Key: 324533023
• Report Number: 2017865-2023-47095
• 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: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD3367-40C
• Device Lot Number: A000133193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• 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