MAUDE Adverse Event Report: ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number	DM2100
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined. .
Event or Problem Description
During follow-up, the device was unable to be interrogated.No intervention has been performed, the device remains implanted and will continue to be monitored.The patient was in stable condition.
Event or Problem Description
Additional information was received indicating premature battery depletion was suspected.
Event or Problem Description
Additional information was received indicating the device was explanted to resolve the event.
Additional Manufacturer Narrative
Upon receipt, the device was unable to be interrogated with a programmer and the reported event of no communication was confirmed.The device was cut open and no source of high current was found during analysis of the hybrid circuit.A longevity estimated was performed and showed premature battery depletion had occurred.The battery underwent further analysis, however the root cause of the premature depletion was undetermined.

• Brand Name: CONFIRM
• Common Device Name: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8678634
• Report Number: 2017865-2019-09109
• Device Sequence Number: 16648430
• Product Code: MXC
• UDI-Device Identifier: 05414734502597
• UDI-Public: 05414734502597
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/30/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: DM2100
• Device Catalogue Number: DM2100
• Device Lot Number: S000050963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 09/25/2019; 12/06/2019; 09/29/2020
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 10/07/2019; 12/13/2019; 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention