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	10/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user reported that subdermal needle electrodes were used during a lumbar fusion procedure.Following procedure, user removed the subdermal needle electrodes and discarded.In post-op it was identified that one of the needle electrodes remained in the patient's thigh and was removed with forceps.During complaint investigation, the user noted that the needle appeared to be intact but detached from the leadwire.The part number was identified as rlsnd121-2.5, lot number pm00023274.

• 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 ; 6783341720
• MDR Report Key: 15853703
• Report Number: 1067162-2022-00005
• Device Sequence Number: 5216524
• Product Code: GXZ
• UDI-Device Identifier: 10816312020141
• UDI-Public: (01)10816312020141
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/23/2022

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 Expiration Date: 04/08/2024
• Device Model Number: RLSND121-2.5
• Device Catalogue Number: RLSND121-2.5
• Device Lot Number: PM00023274
• 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: 10/28/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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: Unknown