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

Model Number	C40+
Medical Device Problem Codes	Circuit Failure (1089); Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it is to 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
The user suddenly experienced that the sound was "bad and loud".
Additional Manufacturer Narrative
Conclusions: device investigation confirmed that the stimulator electronics failed.The failure of the electronic circuitry was probably caused by humidity ingress at detected micro-leaks at the housing braze joint.In addition, a short circuit between two implant channels was present prior to complete loss of function, for undetermined reasons.Other damages found during investigation are most likely related to explantation surgery.The problems described in the recipient report appear to match the damage found.This is a final report.
Event or Problem Description
The user suddenly experienced that the sound was "bad and loud".The user was re implanted.

• Brand Name: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 9985478
• Report Number: 9710014-2020-00236
• Device Sequence Number: 3700615
• Product Code: MCM
• UDI-Device Identifier: 09008737082581
• UDI-Public: (01)09008737082581
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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: 06/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR