MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number	DM2100
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2019
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 a follow-up, upon interrogation, the device was found in backup vvi mode.A firmware reset was attempted but was unsuccessful.No further intervention was performed at this time and the device will continue to be monitored until explant.The patient was stable with no adverse consequences.
Event or Problem Description
The device was explanted.Additional information has been requested but it is unavailable at this time.
Additional Manufacturer Narrative
Upon receipt, the device was unable to be interrogated with a programmer and the reported event of backup operation was unconfirmed.The device was cut open and no source of high current was revealed during analysis of the hybrid circuit.A longevity estimate was performed and revealed premature battery depletion.The battery was sent to the supplier for further analysis, however, the root cause of the premature depletion was undetermined.

• Brand Name: CONFIRM
• Common Device Name: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8252326
• Report Number: 2017865-2019-00728
• Device Sequence Number: 19364116
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/09/2020

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: S000049839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 03/12/2019; 10/23/2019; 09/29/2020
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 03/26/2019; 11/06/2019; 10/09/2020
• 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