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

Model Number 3650

Device Problems Program or Algorithm Execution Problem (4033); Program or Algorithm Execution Failure (4036)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer report number: 2017865-2021-28138.During capture threshold testing, the physician released the button to terminate the testing as expected, however, the device continued to decrement, resulting in a loss of capture.The test continued until completion.The patient had an intrinsic rhythm, so the loss of capture did not result in any patient consequences or adverse events.

Manufacturer Narrative

The device was subject to the decrement test field action issued by abbott on 10 march 2022.

• 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: 12319565
• MDR Text Key: 266443668
• Report Number: 2017865-2021-28136
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: 05414734500661
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2017865-03/10/22¿001¿C
• Patient Sequence Number: 1
• Treatment: GALLANT HF; GALLANT HF