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

Model Number	EX3100
Medical Device Problem Codes	Break (1069); Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the merlin pacing system analyzer exhibited burnt leds, damaged cables, and a damaged, corrosive, rusty battery compartment.There was no patient involvement.
Additional Manufacturer Narrative
Further information was requested but not received.
Additional Manufacturer Narrative
Correction: g2 should have been selected and h6 problem identified before clinical use/exposure should have been selected instead of no health consequences or impact.

• Brand Name: MERLIN PACING SYSTEM ANALYZER
• Common Device Name: 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: 21063374
• Report Number: 2017865-2025-00088
• Device Sequence Number: 8372776
• Product Code: NIK
• UDI-Device Identifier: 05414734503105
• UDI-Public: (01)05414734503105(10)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EX3100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 03/28/2025; 04/01/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 03/28/2025; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown