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

Model Number	3650
Medical Device Problem Codes	No Display/Image (1183); Noise, Audible (3273); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the programmer exhibited an unintended electrical shock upon a clinician and felt pain as a result.An audible pop sound was heard, and the programmer's display went black.The programmer was replaced.There were no consequences, and no patient involvement.
Additional Manufacturer Narrative
The field complaint of programmer power leak was not verified.During analysis, the unit was plugged into an outlet and the power on function was performed.Performed safety and dielectric strength and ground bonding test on unit which are designed to push the programmer to its max capacity using high voltage and to check that the unit is properly grounded.Unit passed both tests.No issues found at time of analysis.The field complaint of black screen was not verified.During analysis, the unit was powered on and screen was lit as expected.The mechanical inspection revealed no damage to the inverter board.No issues found at time of analysis.

• 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 20028741
• Report Number: 2017865-2024-62869
• Device Sequence Number: 8591122
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: (01)05414734500661(10)
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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
• Operator of Device: Health Professional
• Device Model Number: 3650
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown