MAUDE Adverse Event Report: ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number DM3500

Device Problems Failure to Capture (1081); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.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 clinic follow-up, a loss of capture was observed on the device.The device was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

The sterilization records were reviewed and no evidence of abnormal sterilization cycle was found.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 clinic follow-up, redness and itchiness of the device pocket was observed.Additionally, the patient presented with a fever and a loss of contact with the tissue was observed on the device.A loss of capture was not observed on the device.The device was explanted and replaced as a result of the infection.Furthermore, the infection was resolved with antibiotics.The patient was stable.

• Brand Name: CONFIRM
• Type of Device: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9418446
• MDR Text Key: 169300764
• Report Number: 2017865-2019-17274
• 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
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2020
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000070243
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention