MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL, LLC RLSND121-1.5; SUBDERMAL NEEDLE ELECTRODE

Model Number	RLSND121-1.5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a cartoid endarterectomy (cea) a subdermal needle electrode (13mm needle) dislodged in posterior right calf.The user noted that the needle was removed by first removing the tape covering the needle, followed with removal of the needle from the patient.The user noted that the needle tip was detached from the electrode and remained in the patient.A small skin incision was made after cleansing the skin with betadine.Limited wound exploration and ultrasound could not localize the needle to remove it.Two skin closure stitches with 4-0 monocryl were placed and dermabond was applied.An xray was performed.The decision was made to leave the needle in the patient until a future surgery is performed to address this foreign body at a follow-up appointment if the needle tip is causing discomfort or pain.The user noted some potential concern for electrode continuity during stimulation, and noted there was some current return issues in the right leg during the case when paralytic had worn off and patient was moving legs with stimulation.When anesthesia had redosed paralytic, the current return recovered, and the stimulation appeared to be working as normal throughout remainder of the procedure.
Additional Manufacturer Narrative
The full device was not returned for evaluation, the sample consisted of a parallel pair leadwire with one intact electrode and the leadwire junction where the complaint electrode had detached.The complaint sample investigation was performed and identified that the needle electrode appeared to be broken rather than detached from the leadwire; a small portion of the needle was still attached to the leadwire.

• Brand Name: RLSND121-1.5
• Common Device Name: SUBDERMAL NEEDLE ELECTRODE
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL, LLC; 1140 first steet south; columbia SC 29209
• Manufacturer Contact: sandra o'reilly ; 1140 first steet south; columbia, SC 29209 ; 6783341720
• MDR Report Key: 17886875
• Report Number: 1067162-2023-00003
• Device Sequence Number: 12497264
• Product Code: GXZ
• UDI-Device Identifier: 10816312020134
• UDI-Public: 10816312020134
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/06/2023

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 Expiration Date: 12/12/2024
• Device Model Number: RLSND121-1.5
• Device Catalogue Number: RLSND121-1.5
• Device Lot Number: PM00027017
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male