MAUDE Adverse Event Report: ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number DM3500

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Sense (1559); Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2020

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 remote follow up, loss of sensing was noted on the device.It was suspected that the cause of the event was due to device migration, however, no diagnostic imaging was conducted to confirm the supposition.No intervention has been conducted at this time.The patient was stable and will continue to be monitored.

Event Description

Additional information received indicating that the device has also had instances of false readings.The patient was then seen in-clinic for a follow up appointment.The patient's pocket site was palpated and determined that the device has not migrated.The event was resolved by reprogramming the device.There were no known patient consequences.

• Brand Name: CONFIRM
• Type of Device: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10317642
• MDR Text Key: 200196860
• Report Number: 2017865-2020-09146
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: 05415067027320
• Combination Product (y/n): N
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2020

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: 02/19/2021
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: P000087707
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 07/24/2020; 07/24/2020
• Supplement Dates FDA Received: 07/24/2020; 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1