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

Model Number 3650

Device Problems Unintended Application Program Shut Down (4032); Program or Algorithm Execution Failure (4036)

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

Event Date 08/05/2022

Event Type  malfunction  

Event Description

During a follow-up, a threshold decrement test was initiated with the merlin programmer.The test was attempted to be stopped by releasing hold of the test button, however, the programmer continued to execute the decrement test.A new programmer was used to resolve the event.The patient was stable with no consequences.

Manufacturer Narrative

The reported event of the threshold test continuing to decrement following the release of the button was not confirmed.The additional information provided by the field was reviewed by abbott engineering and it was confirmed that the button was not released to stop the test.The test continued and only terminated when the amplitude reached 0.25mv.The device was working as expected and there is no malfunction noted.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15260154
• MDR Text Key: 298244414
• Report Number: 2017865-2022-19859
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: 05414734500661
• 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: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• 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: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2010
• 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