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

Model Number	RLSP503
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During spinal fusion procedure, an electrosurgical unit (esu) pad was placed on the right posterior calf and left posterior thigh.Neuromonitoring needle electrodes were placed bilaterally on patient's shins.The left posterior thigh pad was also not adhering to skin, so a new pad was placed on the left posterior calf.The vendor noted that there was interference in the neuromonitoring feedback.A new pad was placed and relocated to upper right arm.At case conclusion, there were burns noted at multiple electrode sites on bilateral lower extremities.The manufacturer's evaluation of available information concluded that the subdermal needles did not generate and/or transmit energy, therefore the subdermal needles did not contribute to the patient burns.

• Brand Name: RLSP503
• Common Device Name: SUBDERMAL NEEDLE ELECTRODE
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL, LLC; 1140 1st street south; columbia SC 29209
• Manufacturer Contact: sandra o'reilly ; 1140 1st street south; columbia, SC 29209 ; 6783341720
• MDR Report Key: 14320314
• Report Number: 1067162-2022-00001
• Device Sequence Number: 17448359
• Product Code: GXZ
• UDI-Device Identifier: 10816312022428
• UDI-Public: (01)10816312022428
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 10 YR
• Patient Sex: Male
• Patient Weight: 23 KG