MAUDE Adverse Event Report: ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number DM2102

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2022

Event Type  malfunction  

Event Description

During device explant due to normal battery depletion, detachment of the device header was observed.The event was resolved by explanting the device.The patient was in stable condition.

Manufacturer Narrative

Customer complaint of detachment of device header was confirmed.As received, device was visually inspected, and header of the device was found to be cracked and separated from the can due to excessive force by the user.This is consistent with improper handling of the device header by user.Device was received in backup mode with battery at end of service (eos) level due to normal usage.The implant duration exceeds the projected longevity indicating normal battery depletion.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15198443
• MDR Text Key: 304968800
• Report Number: 2017865-2022-17251
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05414734502573
• UDI-Public: 05414734502573
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: DM2102
• Device Catalogue Number: DM2102
• Device Lot Number: S000064645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2018
• 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