MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL. LLC RLSND122-2.5; SUBDERMAL NEEDLE ELECTRODE

Model Number	RLSND122-2.5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, rhythmlink device rlsnd122-2.5, lot unknown was being used during a oblique lumbar interbody fusion and the needle "snapped off," the clinician removed needle with tweezers.It was reported that the stimulation lead was used on the patient's ankle.

• Brand Name: RLSND122-2.5
• 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: 19619638
• Report Number: 1067162-2024-00012
• Device Sequence Number: 15192250
• Product Code: GXZ
• UDI-Device Identifier: 10816312020172
• UDI-Public: 10816312020172
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2024

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 Model Number: RLSND122-2.5
• Device Catalogue Number: RLSND122-2.5
• Device Lot Number: UNKNOWN
• 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: 06/04/2024
• Initial Report FDA Received Date: 06/26/2024
• 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