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

Model Number 3650

Device Problems Application Program Freezes, Becomes Nonfunctional (4031); Program or Algorithm Execution Problem (4033)

Patient Problems Syncope/Fainting (4411); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/08/2021

Event Type  Injury  

Event Description

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 patient was pacemaker dependent.The loss of capture caused a syncopal episode which resulting in the patient hitting their head.The programmer screen was unresponsive and the physician attempted to engage the emergency vvi button unsuccessfully.The programmer was rebooted to resolve the event and patient regained consciousness without additional intervention.The physician estimates that the episode lasted 10-15 seconds.The patient was stable and no further intervention was performed.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.However, session records were sent to abbott systems engineers for review and ventricular decrement capture test that would not cancel, was confirmed.The cause of the reported event was due to an error in the software code.The device history record was performed, and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving manufacturing facilities.

Manufacturer Narrative

This device is included in the decrement test 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: 12046681
• MDR Text Key: 257694907
• Report Number: 2017865-2021-22190
• 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
• 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

• 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
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 09/07/2021; 03/10/2022
• Supplement Dates FDA Received: 09/07/2021; 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2009
• 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
• Patient Outcome(s): Other