MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL, LLC RLSND121-2.5; SUBDERMAL NEEDLE ELECTRODE

Model Number	RLSND121-2.5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, rlsnd121-2.5, lot pm00027786 a paired needle was used during a procedure in which stimulation was being applied to the left ankle, upon completion of the study the needles were being removed and it was visually identified that one of the needles remained retained in the patient.The patient was removed from the or and an xray was taken in pacu and the clinician was able to remove the needle from the patients ankle within a few minutes.

• Brand Name: RLSND121-2.5
• 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: 18907282
• Report Number: 1067162-2024-00009
• Device Sequence Number: 20732527
• Product Code: GXZ
• UDI-Device Identifier: 10816312020141
• UDI-Public: 10816312020141
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/11/2024

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: 02/15/2025
• Device Model Number: RLSND121-2.5
• Device Catalogue Number: RLSND121-2.5
• Device Lot Number: PM00027786
• 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: 02/16/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2023
• 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