MAUDE Adverse Event Report: ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number DM3500

Device Problems Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/02/2021

Event Type  Injury  

Event Description

It was reported that the device was unable to be interrogated.The device was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

Further information was requested but not received.

Event Description

Additional information was received indicating the device was implanted after the expiration date.

Event Description

Additional information was received indicating device was not replaced.

Manufacturer Narrative

The device was received from the field and telemetry was unable to established.The user¿s manual states not to insert the device if ¿use before date¿ has expired.Analysis revealed device battery voltage was at end of life.Further analysis was performed after replacing battery; no anomalies were observed.Longevity assessment was performed, and the implant duration exceeds 75% of total projected longevity indicating normal battery depletion.The reported events of no bluetooth telemetry was confirmed.The cause of the reported event was due to the device being beyond shelf life.

• 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: 12828166
• MDR Text Key: 280878486
• Report Number: 2017865-2021-36823
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: 05415067027320
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2020
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000063710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2018
• 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
• Patient Outcome(s): Required Intervention