MAUDE Adverse Event Report: ABBOTT 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	05/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in the final report.
Event or Problem Description
During follow-up, the device was found in backup mode.The device was explanted and the patient was in stable condition.
Additional Manufacturer Narrative
Additional information: d10, h3, h6.Upon receipt, communication could not be established between the device and the programmer due to the battery being depleted.Based on the default parameter settings, the device did not perform to the expected longevity.The power consumption of the device was measured and found to be normal.The battery was returned to the supplier for analysis; there was no evidence of a cell issue found.The cause of the battery depletion is undetermined.

• Brand Name: CONFIRM
• Common Device Name: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8640504
• Report Number: 2017865-2019-08532
• Device Sequence Number: 19318185
• Product Code: MXC
• UDI-Device Identifier: 05414734502597
• UDI-Public: 05414734502597
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 07/31/2016
• Device Model Number: DM2100
• Device Catalogue Number: DM2100
• Device Lot Number: S000008734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 10/28/2020
• 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