MAUDE Adverse Event Report: ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number DM3500

Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/09/2022

Event Type  malfunction  

Event Description

It was reported that following an episode of syncope, the event was not recorded in the device.Abbott technical support was contacted, the session records were analyzed, and noise was noted on the device.The episode was suspected to not have been recorded due to noise on the device.The physician elected to upgrade the device due to the condition of the patient and the device was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported events of ecg/iegms missing and signal artifact/noise could not be confirmed.The device was received in normal working conditions with battery voltage above elective replacement indicator (eri).Latest session record was analyzed which indicated no anomaly.Analysis performed, including sensing test at field and high sensitivity settings indicated normal device functionality.Longevity assessment was performed and device was in the normal range of operation with appropriate remaining longevity.

• 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: 15495885
• MDR Text Key: 306082429
• Report Number: 2017865-2022-39553
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: 05415067027320
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: P000123415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2021
• 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