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

Model Number	DM2102
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device could not be interrogated.Device explant was anticipated to resolve the event.The patient was stable and will continue to be monitored.There were no adverse consequences.
Event or Problem Description
It was reported that the device could not be interrogated.The device was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.There were no adverse consequences.
Additional Manufacturer Narrative
The reported event of failure to interrogate was not confirmed.Visual inspection found the header broken apart from the device, which is consistent with damage from the explant procedure.Interrogation of the device revealed the device was operating in backup operation mode.Analysis of the device image indicated the device went into backup mode due to low battery voltage, with a power on reset (por).The device was restored and further testing found the device at end of life (eol).A longevity assessment was performed and implant duration exceeded the total projected longevity, indicating normal battery depletion.

• Brand Name: CONFIRM
• Common Device Name: 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: 18955677
• Report Number: 2017865-2024-35592
• Device Sequence Number: 4579555
• Product Code: MXC
• UDI-Device Identifier: 05414734502573
• UDI-Public: 05414734502573
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: DM2102
• Device Lot Number: S000078435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/24/2024; 06/04/2024; 06/06/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/31/2024; 06/06/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown