MAUDE Adverse Event Report: ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number	DM2100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During an elective device upgrade procedure, the physician noted the header of the device became detached while attempting to explant the device.The device was successfully explanted and replaced.The patient was stable with no adverse consequences.
Additional Manufacturer Narrative
Upon receipt, the icm was interrogated with a programmer and communication was successful.The device image and the programmer printouts were obtained.The device was above elective replacement indicator (eri).The icm was visually inspected and it was noted that the header was detached.Scratches and dents, consistent with the explant procedure, were also noted on the device can and header.The device can was bent close to the header side.Due to the detached header, no further testing could be performed.The device history record (dhr) was obtained and reviewed.The icm passed all inspection phases prior to being released for distribution.The reported event of a detached header was verified in the lab and the cause is consistent with procedural damage.

• Brand Name: CONFIRM
• Common Device Name: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8714176
• Report Number: 2017865-2019-09829
• Device Sequence Number: 2275009
• Product Code: MXC
• UDI-Device Identifier: 05414734502597
• UDI-Public: 05414734502597
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K101968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 01/29/2020

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: 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: 07/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1