MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN¿ 2 PATIENT CARE SYSTEM (PCS) PROGRAMMER; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number	MER3700
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the lead parameter checkup procedure, the programmer was shutdown unexpectedly and the programmer fuse was burnt.The programmer was not used and replaced.
Additional Manufacturer Narrative
A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.
Additional Manufacturer Narrative
The field complaint of the programmer not turning on was verified.During analysis, the unit was plugged into a working ac electrical outlet, but the unit did not power on.The fuses were removed and inspected, noting no damage was found.The power supply switch was inspected and tested and found to be fully functional.The ac/dc converter pcb board was inspected, and charring/damage was discovered.After swapping the component with a known working one and the unit was able to power on successfully.The unit failed to power up correctly due to a damaged power supply pcb.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.
Additional Manufacturer Narrative
Correction: h6: previously reported as 4315 - cause not established instead of 4307 - cause traced to component failure in investigation conclusions section.

• Brand Name: MERLIN¿ 2 PATIENT CARE SYSTEM (PCS) PROGRAMMER
• Common Device Name: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• 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: 19113783
• Report Number: 2017865-2024-38499
• Device Sequence Number: 7099583
• Product Code: OSR
• UDI-Device Identifier: 05415067031174
• UDI-Public: (01)05415067031174(10)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/16/2024

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: MER3700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 06/12/2024; 07/05/2024; 08/10/2024; 08/16/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 06/12/2024; 07/05/2024; 08/12/2024; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown