MAUDE Adverse Event Report: ABBOTT UNIFY ASSURA ICD; No Match

Model Number CD3361-40QC

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 07/03/2023

Event Type  Injury  

Manufacturer Narrative

Interrogation of the device revealed it was above elective replacement indicator (eri) when received.Based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).

Event Description

Related manufacturer reference number: (b)(4).It was reported that the device had migrated from the original implant site.The left ventricular (lv) lead was dislodged due to the device migration.The dislodgment was confirm with diagnostic imaging.The device and lv lead were explanted and replaced to resolve the event.The patient was in stable condition.

• 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: 17391097
• MDR Text Key: 319737865
• Report Number: 2017865-2023-36675
• 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
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD3361-40QC
• Device Lot Number: P000150692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2022
• 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
• Patient Outcome(s): Required Intervention