MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Model Number	C40+
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	Headache (1880)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device investigation showed that the stimulator electronics is not working according to specifications.Based on the manufacturer's experience with this kind of devices, it can be assumed that the device has failed due to loss of hermeticity at the housing braze joint.The investigation results appear to match the problems mentioned in the recipient report.This is a combined initial and final report.
Event or Problem Description
The user has been re-implanted on (b)(6) 2022.As per initial information from the field, the user did not have any complaint but wanted to exchange the device for a new one.The user showed good benefit with the device.However, as per later information from the field, the user asked to be reimplanted due to a long-term headache.Reportedly, the user thought that the headaches had a connection with the implant, therefore she thought that a reimplantation will solve the problem and improve the haring sensation (as per friend's experience who has good benefit after being reimplanted).The device was reportedly fully functional.As per further clarification received from the field, according to the user's parents, the user does not experience the sensation of electric or painful shock when not wearing the device.No swelling over the implant area has been observed.The electric and painful shock was experienced starting 5 years ago, sometimes several times in a day or only every couple of days.The shocking and pain sensation could have been a contributor factor which leaded to explantation.

• Brand Name: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
• 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: 16282221
• Report Number: 9710014-2023-00091
• Device Sequence Number: 13111918
• Product Code: MCM
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2023

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: Lay User/Patient
• Device Model Number: C40+
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/02/2023
• 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: 32 YR
• Patient Sex: Female