MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SONATA; COCHLEAR IMPLANT

Model Number	MI1260 SONATA 2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The recipient suffered a hit and a head injury that exposed the implant housing.A repositioning surgery has been performed on (b)(6) 2024.The recipient was seen for a follow-up.Imaging has been performed showing several channels being extra-cochlear.Reportedly, no imaging has been done prior to the intervention on (b)(6) 2024.Another revision surgery was performed on (b)(6) 2025 to re-insert the electrode.The implant was removed, the area was cleaned and the implant was reinserted by means of a posterior tympanotomy (previously it had been done through an endomeatal approach).The recipient was seen for a follow-up on (b)(6) 2025 where he showed good performance with the device.However, in (b)(6) 2025 the device extruded again and revision surgery is scheduled for (b)(6) 2025.
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient suffered from an impact to the head causing an extrusion of the device through the skin.A revision surgery was performed.Post-operative imaging showed that the electrode was likely pulled out of cochlea during the revision surgery.Another revision surgery to re-insert the electrode was performed successfully.However, during this second revision surgery the surgeon removed the implant, cleaned the implant area and re-inserted it, which constitutes an abnormal use.Further, 1 channel was affected afterwards likely due to a damage to the active electrode during the revision surgery.Reportedly in (b)(6) 2025 the device extruded again and another revision surgery was performed.The device remains implanted and in use.
Event or Problem Description
The recipient suffered a hit and a head injury that exposed the implant housing.A repositioning surgery has been performed on (b)(6) 2024.The recipient was seen for a follow-up.Imaging has been performed showing several channels being extra-cochlear.Another revision surgery was performed on (b)(6) 2025 to re-insert the electrode.The implant was removed, the area was cleaned and the implant was reinserted by means of a posterior tympanotomy (previously it had been done through an endomeatal approach).The recipient was seen for a follow-up on (b)(6) 2025 where he showed good performance with the device.However, in (b)(6) 2025 the implant housing extruded again.A further revision surgery was performed on (b)(6) 2025.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the recipient suffered from an impact to the head causing an extrusion of the device through the skin.A revision surgery was performed.Post-operative imaging showed that the electrode was likely pulled out of cochlea during the revision surgery.Another revision surgery to re-insert the electrode was performed successfully.However, during this second revision surgery the surgeon removed the implant, cleaned the implant area and re-inserted it, which constitutes an abnormal use.Further, 1 channel was affected afterwards likely due to a damage to the active electrode.Reportedly the device extruded again and was therefore explanted.Device investigation revealed damage to the active electrode likely caused by device minute mobility.In addition the magnet force was found slightly out of specification, however no information on a possible magnet resonance imaging or similar has been received.Apart from that the magnet works within specification.Other mechanical damages found are attributable to the removal surgery.This is a final report.
Event or Problem Description
The recipient suffered a hit and a head injury that exposed the implant housing.A repositioning surgery has been performed on (b)(6) 2024.The recipient was seen for a follow-up.Imaging has been performed showing several channels being extra-cochlear.Another revision surgery was performed on (b)(6) 2025, to re-insert the electrode.The implant was removed, the area was cleaned and the implant was reinserted by means of a posterior tympanotomy (previously it had been done through an endomeatal approach).The recipient was seen for a follow-up on (b)(6) 2025, where he showed good performance with the device.However, in (b)(6) 2025 the implant housing extruded again.The skin has again opened behind the ear, as reported in (b)(6) 2025.The device was explanted.

• Brand Name: SONATA
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 21992599
• Report Number: 9710014-2025-00422
• Device Sequence Number: 8312795
• Product Code: MCM
• UDI-Device Identifier: 09008737385439
• UDI-Public: (01)09008737385439
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 04/03/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/09/2025
• Device Model Number: MI1260 SONATA 2
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 05/05/2025; 05/05/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 05/14/2025; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Male