MAUDE Adverse Event Report: ABBOTT CONFIRM; RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)

Model Number DM3500

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332)

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

Event Date 10/30/2023

Event Type  malfunction  

Event Description

During an in-clinic follow-up, the device was unable to be interrogated via bluetooth low energy telemetry.Premature battery depletion was suspected to be the cause of the event.No intervention was performed at this time.The patient was stable and will continue to be monitored.

Event Description

Additional information received indicated the device was later explanted to resolve the event.The patient was in stable condition.

Manufacturer Narrative

Reported event of premature discharge of battery and failure to interrogate were not confirmed.The device was above elective replacement indicator (eri) level upon receipt.Analysis of device image indicated device was within normal range of operation.Further analysis performed found no anomaly with the device able to be interrogated successfully with merlin programmer.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: CONFIRM
• Type of Device: RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)
• 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: 18132264
• MDR Text Key: 328063399
• Report Number: 2017865-2023-52382
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: 05415067027320
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K163407
• 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: 01/30/2024

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: 04/28/2023
• Device Model Number: DM3500
• Device Lot Number: P000134464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 12/06/2023; 01/26/2024
• Supplement Dates FDA Received: 12/12/2023; 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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