MAUDE Adverse Event Report: TECHNOMED EUROPE NEUROSIGN; DISPOSABLE TWISTED PAIR ELECTRODE

Model Number	1699-00-TE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The metal portion of the needle electrode broke off in the patient and had to be cut out.A scoliosis correction was being performed.All needle electrodes, grounds, corkscrews and adhesive electrode placed as usual and procedure commenced.Nothing unusual to report during the procedure.After the procedure, it was noticed one needle was missing, an x-ray was taken and the needle found in the patient, at the knee.The needle was cut out to be removed.The patient is doing fine.There was no change in surgical outcome and no impact on patient health.The needle could easily be found and the cut made was described as very small.A small plaster and few stitches were used to close the wound.
Event or Problem Description
The metal portion of the needle electrode broke off in the patient and had to be cut out.A scoliosis correction was being performed.All needle electrodes, grounds, corkscrews and adhesive electrode placed as usual and procedure commenced.Nothing unusual to report during the procedure.After the procedure, it was noticed one needle was missing, an x-ray was taken and the needle found in the patient, at the knee.The needle was cut out to be removed.The patient is doing fine.There was no change in surgical outcome and no impact on patient health.The needle could easily be found and the cut made was described as very small.A small plaster and few stitches were used to close the wound.

• Brand Name: NEUROSIGN
• Common Device Name: DISPOSABLE TWISTED PAIR ELECTRODE
• Manufacturer (Section D): TECHNOMED EUROPE; amerikalaan 71; maastricht-airport, limburg 6199 AE; NL 6199 AE
• Manufacturer (Section G): TECHNOMED ASIA; k.i. trikencana kav. 4-5, jl.; kopo katapang km 11; bandung, jawa barat 40921 ; ID 40921
• Manufacturer Contact: sanne habets ; amerikalaan 71; maastricht-airport, limburg 6199 -AE ; NL 6199 AE
• MDR Report Key: 17235379
• Report Number: 9710376-2023-00001
• Device Sequence Number: 5754779
• Product Code: GXZ
• UDI-Device Identifier: 08718375864845
• UDI-Public: 08718375864845
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K130136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1699-00-TE
• Device Catalogue Number: 1699-00-TE
• Device Lot Number: 056631 OR 054787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2021
• 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 Age: 13 YR
• Patient Sex: Female