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

Model Number CD3367-40C

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

Patient Problem Dizziness (2194)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the patient presented with complaints of dizziness.Upon investigation, noise resulting in oversensing and pacing inhibition was observed on the right ventricular (rv) channel.The event was reproducible with device provocation testing.The device was explanted and replaced to resolve the event as the event and the patient was in stable condition.The noise was not reproducible after the replacement device was connected to the rv lead.

Manufacturer Narrative

The reported field event of oversensing and loss of pacing could not be reproduced in the lab.A visual inspection of the septum, setscrew, and contact spring did not reveal any anomaly that could contribute to the reported event.The telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and observed to be normal.

• Brand Name: QUADRA 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: 17184878
• MDR Text Key: 317719325
• Report Number: 2017865-2023-23932
• 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: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: CD3367-40C
• Device Lot Number: P000132789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2021
• 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