MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA MP ICD; NO MATCH

Model Number CD3371-40QC

Device Problems Over-Sensing (1438); No Pacing (3268)

Patient Problem Dizziness (2194)

Event Date 06/27/2023

Event Type  malfunction  

Event Description

During follow-up, myopotential oversensing resulting in pacing inhibition and dizziness was observed in a pacemaker dependent patient.Abbott technical support was contacted and confirmed the event.The event was resolved by reprogramming the device.The patient was in stable condition and experienced no adverse health consequences.

• Brand Name: QUADRA ASSURA MP 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: 17225712
• MDR Text Key: 318109600
• Report Number: 2017865-2023-24673
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 08/15/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: CD3371-40QC
• Device Lot Number: P000106134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• 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