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

Model Number CD3361-40C

Device Problems High impedance (1291); Failure to Disconnect (2541); Connection Problem (2900)

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

Event Date 04/06/2023

Event Type  malfunction  

Event Description

It was reported that the set screw was unable to be removed from the device header.Additionally, the lead was unable to be inserted completely which resulted in high pacing impedance on the right ventricular channel.The device was explanted and replaced to resolve the event and the patient was in stable condition.

Manufacturer Narrative

The reported field event of set screw connection anomaly was confirmed and the reported event of high pacing impedance could not be confirmed.Analysis revealed the right ventricular lead set screw was stripped and contained septum material inside the hex cavity.This material in the hex cavity prevented full insertion of the torque driver and was the cause of the reported event.The set screw anomaly was consistent with having occurred during the procedure.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16811593
• MDR Text Key: 313993726
• Report Number: 2017865-2023-18403
• 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: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD3361-40C
• Device Lot Number: P000161902
• 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: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2023
• 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