MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN PROGRAMMER; PROGRAMMER, PACEMAKER

Model Number 3650

Device Problem Program or Algorithm Execution Failure (4036)

Patient Problem Arrhythmia (1721)

Event Date 02/02/2021

Event Type  Injury  

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

The patient was interrogated the day after implant for check-up using merlin programmer.During capture threshold testing for the left ventricular lead, the user released the button to terminate the testing as expected, however, the device continued to decrement, resulting in a loss of capture.The patient had no long term effects due to the pauses.The threshold testing was completed successfully using the wand only.It was noted that the patient was dependent.The right atrial and ventricular leads were assessed successfully.The patient was in stable condition.

Event Description

Decrement test field action issued by abbott on (b)(4) 2022.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 11362132
• MDR Text Key: 233022858
• Report Number: 2017865-2021-09270
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,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

• Date FDA Received: 02/22/2021
• 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
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 69 YR
• Patient Sex: Male