MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN PROGRAMMER; NO MATCH

Model Number 3650

Device Problem Program or Algorithm Execution Failure (4036)

Patient Problems Arrhythmia (1721); Discomfort (2330)

Event Date 11/07/2023

Event Type  Injury  

Event Description

It was reported the device was subject to the decrement test field action issued by abbott on (b)(6) 2022.The patient had experienced asystole and discomfort temporarily.No intervention was performed.There were no patient consequences.

Manufacturer Narrative

The reported event of threshold test not aborting was not confirmed.Based on the information provided, the right ventricular threshold test was determined to have been terminated.However, the programmer may have experienced a delay in termination due to a touch screen anomaly, resulting in the test continuing to decrement.The root cause was unable to be determined.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: NO MATCH
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18235130
• MDR Text Key: 329315282
• Report Number: 2017865-2023-93551
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00541473450066
• UDI-Public: 0541473450066
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model 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: 03/28/2024
• 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
• Treatment: GALLANT HF
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male