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

Model Number CD3361-40C

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959)

Patient Problems Fatigue (1849); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2022

Event Type  Injury  

Event Description

Related manufacturer report number: 2017865-2022-39592 and 2017865-2022-39594.The pacemaker dependent patient attended the emergency room after receiving an inappropriate high voltage shock.The device was interrogated and was observed to be in backup mode.Abbott technical support was contacted and a firmware download was performed to resolve the event.During analysis of the session records, noise resulting in oversensing was observed on the right ventricular (rv) lead.Following the firmware download, a loss of capture was observed on the left ventricular (lv) lead.The physician suspected rv lead externalization and lv lead damage.Fluoroscopy was performed and revealed no anomalies.No intervention has been performed at this time.The patient was in stable condition.

Event Description

Additional information received indicated the event was resolved by explanting and replacing the device and right ventricular (rv) lead.Insulation damage was visually confirmed on the rv lead.Following rv lead replacement left ventricular (lv) lead capture was present and the previous loss of capture was suspected to be due to the rv lead.No further intervention was performed with the lv lead.Further information was requested but is not yet available.

Event Description

Additional information received indicated the patient presented with faintness.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15496988
• MDR Text Key: 300696032
• Report Number: 2017865-2022-39591
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: CD3361-40C
• Device Lot Number: A000019337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2016
• 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; Life Threatening