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

Model Number CD3371-40QC

Device Problems Failure to Charge (1085); Noise, Audible (3273)

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

Event Date 07/13/2021

Event Type  Injury  

Event Description

It was reported that an alert for capacitor charge time out was received.During a clinic follow-up, manual charging was attempted, but was unsuccessful.Additionally, an audible noise was heard from the device during the maintenance test.Technical support was contacted and recommended device replacement.A device exchange is anticipated, but has not been performed at this time.The patient was stable and will continue to be monitored.

Event Description

Additional information was received indicating the device was explanted and replaced to to resolve the event.The patient was stable.

Manufacturer Narrative

The reported event of charge time out was confirmed in the lab.Interrogation of the device revealed the device was above the elective replacement indicator when received.Pacing, sensing, impedance, and patient notifier was tested, no anomaly was detected.The cause of the field event is an internal 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12266936
• MDR Text Key: 264731096
• Report Number: 2017865-2021-27293
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 12/15/2021

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: 06/30/2020
• Device Model Number: CD3371-40QC
• Device Lot Number: A000060754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 08/05/2021; 11/30/2021
• Supplement Dates FDA Received: 08/19/2021; 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2018
• 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