MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH ANTS; MUSCLE / NEUROSTIMULATION SYSTEM

Model Number	ANTS ELECTRODE
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.Please be aware that this report currently identifies mi1200 synchrony as the selected device; however, the report pertains to the ants (auditory nerve test system electrode) (b)(6).This discrepancy will be corrected in the final report.
Event or Problem Description
Despite proper connection and satisfactory integrity tests, the ants (auditory nerve test system) electrode failed to transmit a signal due to high impedances, preventing the intended hearing nerve assessment, and resulting in no ci implantation.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the ants electrode failed to transmit a signal due to high impedances during implantation surgery.Therefore no cochlear implant was implanted.Device investigation revealed a mechanical damage of the ants electrode due to multiple overload wire fractures.As device history record review confirms that the device was released within specification, the observed damage was most likely caused, inadvertently, during intraoperative handling.This is a final report.
Event or Problem Description
Despite proper connection and satisfactory integrity tests, the ants (auditory nerve test system) electrode failed to transmit a signal due to high impedances, preventing the intended hearing nerve assessment, and resulting in no ci implantation.

• Brand Name: ANTS
• Common Device Name: MUSCLE / NEUROSTIMULATION SYSTEM
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 21544528
• Report Number: 9710014-2025-00161
• Device Sequence Number: 15208384
• Product Code: MCM
• UDI-Device Identifier: 09008737371371
• UDI-Public: (01)09008737371371
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: ANTS ELECTRODE
• Device Lot Number: SN: 103029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female