MAUDE Adverse Event Report: ABBOTT FORTIFY ASSURA VR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD1359-40QC

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Under-Sensing (1661); No Pacing (3268)

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

Event Date 07/26/2022

Event Type  Injury  

Event Description

It was reported that during a remote follow up, inappropriate anti-tachycardia pacing (atp) was noted on the device.Additionally undersensing was noted on the device resulting in pacing inhibition.Abbott technical support was contacted and the device was reprogrammed to resolve the event.The patient was in stable condition.

Manufacturer Narrative

Session records were provided for review by technical services.Analysis of the session records indicated that the undersensing resulting in pacing inhibition and inappropriate atp event was sensed by the device.

• Brand Name: FORTIFY ASSURA VR ICD, US
• 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: 15210126
• MDR Text Key: 297700294
• Report Number: 2017865-2022-17359
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: CD1359-40QC
• Device Lot Number: P000140667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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