MAUDE Adverse Event Report: ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number DM3500

Device Problem Misconnection (1399)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2020

Event Type  malfunction  

Event Description

During a revision procedure, there was a separation of the device header from the main body.The device was explanted to resolve the event and the patient was in stable condition.

Manufacturer Narrative

Please note, adverse event previously selected and hospitalization and required intervention to prevent permanent impairment/damage the results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Additional information was received indicating the device was explanted due to normal end-of-life (eol).

Manufacturer Narrative

The device was received with the header broken off from the device.Visual inspection found tool marks on the device and header which was consistent with explant damage.Further analysis on session record indicated that device had normal battery depletion.The total projected longevity was 2.0 years and the device was implanted for 2.35 years, which exceeded projected longevity and is considered normal eol.

• Brand Name: CONFIRM
• Type of Device: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9633184
• MDR Text Key: 176449105
• Report Number: 2017865-2020-01010
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: 05415067027320
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2018
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000031682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention