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 unspecified.During a carotid endarterectomy, a rhythmlink device (rlsp503, lot number unknown) was used, and it was reported that the needle detached from the leadwire and was left in the patient's arm.The needle was discovered after closure and was removed using tweezers.Images were taken to confirm that no fragments of the needle remained.

• 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: 21263584
• Report Number: 1067162-2025-00002
• Device Sequence Number: 4276704
• 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
• 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