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

Model Number 3650

Device Problems Data Problem (3196); Unexpected Shutdown (4019); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Arrhythmia (1721)

Event Date 11/07/2023

Event Type  Injury  

Manufacturer Narrative

Further information was requested, but not yet received.

Event Description

Related manufacturer reference number: 2017865-2023-93573 / 2017865-2023-93574.It was reported that the patient experienced a right ventricular (rv) lead cardiac perforation.The patient presented for a lead revision.The lead was capped and replaced on (b)(6) 2023.While implanting the new rv lead, the patient went into complete heart block.An attempt was made to re-program the rv lead to max output, but the merlin programmer froze, displaying an error message and the system shut down.As a result, there was no back up pacing during this time.Ultimately, the merlin programmer was reset, and the procedure was completed without further complications.The patient condition was stable post-procedure.

• 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: 18238346
• MDR Text Key: 329381004
• Report Number: 2017865-2023-93577
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: 05414734500661
• 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
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/16/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GALLANT,; LEFT VENTRICULAR LEAD,; ULTIPACE.
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female