MAUDE Adverse Event Report: ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number	DM2100
Medical Device Problem Codes	Failure to Interrogate (1332); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
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 an in-clinic follow up, the device was found in back up mode.Technical support was contacted and it was determined that the cause of the event was most likely due to the device being at its elective replacement indicator/ end-of-life stage.No intervention has been conducted at this time but device replacement is anticipated at the next in-clinic follow up.The patient was stable with no consequences.
Additional Manufacturer Narrative
Additional information: b5 and h6.
Event or Problem Description
Additional information received indicating that the device was attempted to be interrogated but was unsuccessful.

• Brand Name: CONFIRM
• Common Device Name: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10587772
• Report Number: 2017865-2020-14256
• Device Sequence Number: 2977375
• Product Code: MXC
• UDI-Device Identifier: 05414734502597
• UDI-Public: 05414734502597
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 10/31/2017
• Device Model Number: DM2100
• Device Catalogue Number: DM2100
• Device Lot Number: S000025264
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1