MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL, LLC RLSP310; SUBDERMAL NEEDLE ELECTRODE

Model Number	RLSP310
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 02/22/2024, rhythmlink device rlsp310, lot r0000005918 was used during a procedure and somatosensory evoked potential disappeared in all channels in the right lower extremity.Upon removal it was noticed immediately that the needle was missing from the white leadwire and it was later confirmed with xray that the needle remained in the patient.

• Brand Name: RLSP310
• 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 street south; columbia, SC 29209 ; 8033659657
• MDR Report Key: 18907443
• Report Number: 1067162-2024-00010
• Device Sequence Number: 6248388
• Product Code: GXZ
• UDI-Device Identifier: 10816312022244
• UDI-Public: 10816312022244
• 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): Unknown
• 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: 02/06/2025
• Device Model Number: RLSP310
• Device Catalogue Number: RLSP310
• Device Lot Number: R0000005918
• 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: 02/26/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2023
• 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