MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL, LLC. RLSP503; SUBDERMAL NEEDLE ELECTRODE

Model Number	RLSP503
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
The date of the event is unknown, but during a posterior spinal fusion procedure (t2-l4) lasting 11-12 hours, a rhythmlink device (rlsp503, lot number unknown) was used.After the removal of the needles, skin discoloration was noticed on the patient's skin, but no needle was observed in the area.The following day, it was discovered that a portion of the needle had remained in the patient's wrist area.The device and needle fragment were discarded by the user facility and, as a result, could not be returned for evaluation.

• Brand Name: RLSP503
• Common Device Name: SUBDERMAL NEEDLE ELECTRODE
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL, LLC.; 1140 first street south; columbia SC 29209
• Manufacturer Contact: sandra o'reilly ; 1140 first street south; columbia, SC 29209
• MDR Report Key: 21263398
• Report Number: 1067162-2025-00001
• Device Sequence Number: 4336220
• Product Code: GXZ
• UDI-Device Identifier: 10816312022428
• UDI-Public: 10816312022428
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: RLSP503
• Device Catalogue Number: RLSP503
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown