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

Model Number CD3361-40QC

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

It was reported that during an unrelated procedure, the set screws of the device was unable tighten.The device was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported event of set screw unable to tighten was confirmed.The device was above elective replacement indicator (eri) level upon receipt.Analysis revealed the atrial 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 left ventricular set screw was backed out from its thread as a result of unscrewing the set screw too far, contained septum material inside the cavity, and was partially stripped.When the screw was re-engaged with the connector block, the screw operated normally in affixing the test lead to the header.The right ventricular set screw was found to be normal and was able to secure the leads.The set screw anomaly was consistent with having occurred during the procedure.

• Brand Name: UNIFY 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: 17824122
• MDR Text Key: 324342148
• Report Number: 2017865-2023-47103
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD3361-40QC
• Device Lot Number: P000173263
• 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: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2023
• 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