MAUDE Adverse Event Report: ABBOTT CONFIRM; RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)

Model Number DM2102

Device Problems Failure to Interrogate (1332); Incorrect, Inadequate or Imprecise Result or Readings (1535); Under-Sensing (1661)

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

Event Date 10/24/2023

Event Type  malfunction  

Event Description

During an in-clinic follow-up, the device was unable to be interrogated and delivered an error message.In addition, previous episodes of undersensing were also observed on the device.Abbott technical support was contacted and suspected a corrupt egm was the cause of the event.No intervention was performed at this time.The patient was stable and will continue to be monitored.

Event Description

Additional information received indicated the patient was later seen in clinic, and the device was reprogrammed to resolve the event.The patient was in stable condition.

• Brand Name: CONFIRM
• Type of Device: RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18093026
• MDR Text Key: 327639476
• Report Number: 2017865-2023-51905
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05414734502573
• UDI-Public: 05414734502573
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K133481
• 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: 11/15/2023

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: 10/31/2022
• Device Model Number: DM2102
• Device Lot Number: S000084208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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