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

Model Number CD3361-40C

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); No Apparent Adverse Event (3189)

Patient Problems Dizziness (2194); Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2022

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

Patient presented in-clinic after experiencing episodes of dizziness and syncope.Upon investigation, noise resulting in oversensing, pacing inhibition, and inappropriate anti-tachycardia pacing (atp) were observed on the right ventricular channel.The oversensing could be reproduced during provocative testing.The device was temporarily reprogrammed, the patient was hospitalized, and device revision is anticipated.The patient was stable and will continue to be monitored.

Manufacturer Narrative

Correction: upon review, the pulse generator should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.

Event Description

Additional information received indicated the reported event of noise resulting in oversensing, pacing inhibition, and inappropriate therapy were caused by the non-abbott right ventricular lead.A revision procedure was performed to replace the non-abbott lead and the abbott device was left implanted.No allegation of malfunction was made against the abbott device.The patient was stable.

• 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: 16158643
• MDR Text Key: 307297763
• Report Number: 2017865-2023-01117
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

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 Expiration Date: 11/30/2017
• Device Model Number: CD3361-40C
• Device Lot Number: S000013508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2015
• 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): Other