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

Model Number CD3371-40QC

Device Problems Failure to Charge (1085); Over-Sensing (1438); Noise, Audible (3273)

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

Event Date 03/07/2023

Event Type  Injury  

Event Description

It was reported that during a follow up in clinic, noise resulting in oversensing was noted on the device during a capacitor maintenance resulting in a capacitor charge time-out.Provocative testing was performed and the noise was unable to be reproduced.Manual capacitor maintenance was performed in clinic, capacitor charge time-out occurred, and auditory noise was heard.Abbott technical support was contacted and the device was reprogrammed to disable high voltage therapy.The device was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported event of noise, oversensing, and charge timeout was confirmed.Noise was recorded in the device image and was determined by tech services to be due to emi (electromagnetic interference) from charging.The noise was also being over sensed, but the device behaved as programmed.Charge timeout was also recorded in the device image.The cause of the charge timeout was due to a high voltage capacitor anomaly.

• Brand Name: QUADRA ASSURA MP 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: 16639231
• MDR Text Key: 312255203
• Report Number: 2017865-2023-16169
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: CD3371-40QC
• Device Lot Number: A000112974
• 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: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2021
• 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