MAUDE Adverse Event Report: ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number DM2102

Device Problems Failure to Interrogate (1332); Incorrect, Inadequate or Imprecise Result or Readings (1535); Computer Operating System Problem (2898)

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

During a follow-up in clinic, a corrupted electromyography restricted the physician from interrogating the device successfully.Technical support was contacted and confirmed the interrogation issue was due to firmware corruption.A firmware download is anticipated on the device.The patient was stable.

Event Description

Additional information received confirmed the device was reprogrammed to resolve the event.

• 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: 11372496
• MDR Text Key: 233280198
• Report Number: 2017865-2021-09467
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: DM2102
• Device Catalogue Number: DM2102
• Device Lot Number: S000067808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 02/24/2021; 04/23/2021
• Supplement Dates FDA Received: 02/24/2021; 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• 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