MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number	MI1000 MED-EL CONCERT PIN
Medical Device Problem Codes	Circuit Failure (1089); Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/28/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On august 28, the user suddenly heard a loud sound comparable of a drill.She had to take off the speech processor as it was very loud.She was able to put it back the following day but again after a while she heard the same noise again.Since then, she constantly hears that noise and therefore is unable to put the processor on.
Event or Problem Description
On august 28, the user suddenly heard a loud sound comparable of a drill.She had to take off the speech processor as it was very loud.She was able to put it back the following day but again after a while she heard the same noise again.Since then, she had constantly heared that noise and therefore was unable to put the processor on.The user was reimplanted with a new deivce on (b)(6) 2021.
Additional Manufacturer Narrative
Conclusion: device investigation confirmed that the stimulator electronics is not working according to specifications.The failure of the electronic circuitry was likely caused by humidity ingress at the detected micro-leaks at the housing's header assembly.Over a certain period of time, humidity will impinge on the electronics and cause damage, potentially leading to complete failure of the circuitry.The investigation findings appear to match the content of the patient report.This is a final report.

• Brand Name: MED-EL MAESTRO 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: 12512057
• Report Number: 9710014-2021-00708
• Device Sequence Number: 4032138
• Product Code: MCM
• UDI-Device Identifier: 09008737083625
• UDI-Public: (01)09008737083625
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• 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): 07/04/2022

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: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 08841
• 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: 09/17/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 07/04/2022
• 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: 11 YR
• Patient Sex: Female