MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number	DM2100
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not returned to manufacturer.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
It was reported the asymptomatic patient presented in clinic for a follow up.When interrogation was attempted on the implantable cardiac monitor, it was unable to be performed.It was suspected the device had premature battery depletion as the reason for the interrogation issues.The device was explanted.There were no patient consequences.
Additional Manufacturer Narrative
Additional information: d9 analysis was completed.Interrogation issues were confirmed.The cause of the no communication was found to be due to low battery voltage from premature depletion.The cause of the premature depletion remains undetermined.Testing did not find any anomalies.

• Brand Name: CONFIRM
• Common Device Name: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10411973
• Report Number: 2017865-2020-11479
• Device Sequence Number: 14153900
• Product Code: MXC
• UDI-Device Identifier: 05414734502597
• UDI-Public: 05414734502597
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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
• 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: 08/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 08/16/2020
• Supplement Report FDA Received Date: 01/19/2021
• 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: Required Intervention