MAUDE Adverse Event Report: ABBOTT CRM CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number DM3500

Device Problems Application Program Version or Upgrade Problem (2881); Wireless Communication Problem (3283)

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2019

Event Type  malfunction  

Event Description

The device was unable to be upgraded with the most recent firmware.Technical support was contacted but the upgrade was unsuccessful.There was no patient involved.

Manufacturer Narrative

The device was received with battery voltage at end of life level and no ble communication.Analysis performed after installing a new battery and reloading product code revealed accelerated battery depletion.Further investigation performed on the hybrid indicated a ble communication anomaly, as seen in the field, which also resulted in accelerated battery depletion.This is consistent with a ble ic anomaly on the hybrid.The reported event was confirmed.

• Brand Name: CONFIRM
• Type of Device: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ABBOTT CRM; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT CRM; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8654165
• MDR Text Key: 146505770
• Report Number: 2017865-2019-08403
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: 05415067027320
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2019
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000056352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2017
• 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