MAUDE Adverse Event Report: Technomed Europe Neuroguard; Disposable Subdermal Needle Electrode, parallel

Model Number	S46-937
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Technomed received a complaint via distributor consolidated neuro supply regarding a subdermal needle electrode used for posterior tibial nerve (ptn) stimulation.During removal of the needle from the patient's ankle, the needle reportedly broke, leaving a portion retained in the patient.An x-ray was performed and confirmed that the needle remained in the patient's ankle.Attempts to remove the retained portion using a magnet and hemostats were unsuccessful.It was subsequently reported that the patient was in interventional radiology for removal of the retained needle.The affected product was identified as ref.S46-937, lot 104474.
Additional Manufacturer Narrative
Internal investigation found no anomalies or product defects in retained samples.The event was considered consistent with the product's mechanical capability being exceeded rather than a systematic product issue.
Event or Problem Description
Technomed received a complaint via distributor consolidated neuro supply regarding a subdermal needle electrode used for posterior tibial nerve (ptn) stimulation.During removal of the needle from the patient's ankle, the needle reportedly broke, leaving a portion retained in the patient.An x-ray was performed and confirmed that the needle remained in the patient's ankle.Attempts to remove the retained portion using a magnet and hemostats were unsuccessful.It was subsequently reported that the patient was in interventional radiology for removal of the retained needle.The affected product was identified as ref.S46-937, lot 104474.
Additional Manufacturer Narrative
The manufacturer's investigation has been completed.The device was not returned for evaluation as it had been disposed of by the hospital.Evaluation of retained samples and review of the manufacturing and traceability records identified no abnormalities or relevant deviations.A definitive root cause could not be established.No evidence of a systematic product or manufacturing issue was identified.

• Brand Name: Neuroguard
• Common Device Name: Disposable Subdermal Needle Electrode, parallel
• Manufacturer (Section D): Technomed Europe; wiebachstraat 25a; kerkrade, limburg 6466N G; NL 6466NG
• Manufacturer (Section G): Technomed Asia; k.i trikencana kav. 4-5, jl; kopo katapang km 11; bandung, jawa barat 40921 ; ID 40921
• Manufacturer Contact: isabelle fiandaca ; wiebachstraat 25a; kerkrade, limburg 6466N-G ; NL 6466NG
• MDR Report Key: 50566122
• Report Number: 9710376-2026-00004
• Device Sequence Number: 15977027
• Product Code: GXZ
• UDI-Device Identifier: 08718375863275
• UDI-Public: 08718375863275
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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?: Yes
• Device Model Number: S46-937
• Device Catalogue Number: A001001
• Device Lot Number: 104474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown