MAUDE Adverse Event Report: ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number DM3500

Device Problem Signal Artifact/Noise (1036)

Patient Problem Syncope (1610)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient experienced an episode of syncope.Upon interrogation, the device displayed no episodes of syncope due to suspected noise.A device upgrade procedure was performed which was unrelated to the event and the patient was in stable condition.

Manufacturer Narrative

Analysis performed indicated the device exhibited normal characteristics.A sensitivity test was performed on the device with various settings and it was able to sense within the product specification.Visual inspection did not find any foreign material on the header feed through pin that could contribute to the noise complaint.A longevity assessment was performed and device was in the normal range of operation with appropriate remaining longevity.The reported event of noise was not confirmed.

• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9586385
• MDR Text Key: 175706308
• Report Number: 2017865-2020-00397
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2020
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000069523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2019
• 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