MAUDE Adverse Event Report: ABBOTT MERLIN PROGRAMMER; PROGRAMMER, PACEMAKER

Model Number 3650

Device Problem Program or Algorithm Execution Failure (4036)

Patient Problems Arrhythmia (1721); Asystole (4442)

Event Date 02/07/2023

Event Type  Injury  

Event Description

During a follow-up, when testing the capture threshold, a loss of capture was noted.When noted, an attempt was unsuccessfully made to cancel the capture testing on the programmer.The extending the loss of capture from the testing, resulted in asystole.The programmer ended the test which resolving the issue.The physician estimates that the episodes lasted 2 seconds.That patient was stable and no further intervention was performed.

Manufacturer Narrative

The reported event of threshold test continuing following the release of the test button could not be confirmed.The device records were reviewed by an abbott software engineer, based on the information provided, there was no indication that the button was released to end the atrial decrement capture test and the right ventricle decrement capture test was appropriately aborted, but there was a delay to revert back to permanent settings.The physical programmer was not returned; thus, further investigation into the cause of the reported event could not be performed.Based on the available evidence, the cause of the field event was unable to be determined.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PROGRAMMER, PACEMAKER
• 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: 16455825
• MDR Text Key: 310381252
• Report Number: 2017865-2023-10779
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030054
• 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: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3650
• Device Catalogue Number: 3650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2010
• 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
• Patient Outcome(s): Other