MAUDE Adverse Event Report: ABBOTT MERLIN PROGRAMMER; NO MATCH

Model Number 3650

Device Problem Program or Algorithm Execution Failure (4036)

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

Event Date 07/31/2023

Event Type  malfunction  

Event Description

It was reported, during threshold testing the merlin programmer did not stop the threshold test when the testing button was released, the test continue until minimum output.The patient did not experience any adverse consequences due to the test continuing.The patient was stable.

Manufacturer Narrative

The field complaint of programmer functionality issue was not verified as the event could not be reproduced.

Manufacturer Narrative

The reported event of the threshold test continuing after release of the test button was confirmed via review of the device session.Based on the information provided, the root cause of the failed decrement capture test was unable to be determined.There were no additional findings related to the event.The top housing of the programmer was replaced and all tests performed were normal.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: NO MATCH
• 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: 17600004
• MDR Text Key: 321714769
• Report Number: 2017865-2023-38992
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: 05414734500661
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1