MAUDE Adverse Event Report: ABBOTT MERLIN PROGRAMMER; No Match

Model Number 3650

Device Problems Failure to Power Up (1476); Sparking (2595); Noise, Audible (3273)

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

Event Type  malfunction  

Manufacturer Narrative

The reported event of programmer unable to turn on and audible noise and visual sparking from programmer power source were not confirmed by analysis.The unit was plugged in to an external power source and powered on.The system was able to boot up successfully.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found damage to the printer.

Event Description

It was reported that the programmer was unable to be turned on.Audible noise and visual sparking was observed from the power source of the programming.No adverse consequences were reported for the patient or the user.The programmer was replaced.

• 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: 17568314
• MDR Text Key: 321400606
• Report Number: 2017865-2023-38558
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: 05414734500661
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3650
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2010
• 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