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

Model Number	MI1200 SYNCHRONY PIN
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been explanted and has been returned to innsbruck where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
Event or Problem Description
The recipient was reimplanted due to dislocation of electrode contacts.
Additional Manufacturer Narrative
Device investigation revealed a mechanically damaged electrode array i.E.Several electrode contacts were found dislocated from the silicone body, which is possible to occur during surgical interventions and was likely related to the observed kinking of the electrode.In fact, post-operative imaging showed basal kinking of the electrode array in the cochlea after implantation, which was probably induced by surgical and clinical reasons.Furthermore, no full insertion was achieved at initial implantation surgery.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
Event or Problem Description
After initial implantation, imaging showed electrodes passing through the round window with kinking and folding of the electrode array in the first 3 mm of the basal turn.Also, during the insertion, the electrode contacts appeared to be disconnected from the silicon.Per the implant registration card, 2 electrodes were left extra-cochlear.The device was never activated, and the recipient was re-implanted 5 days after initial surgery.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 8752060
• Report Number: 9710014-2019-00512
• Device Sequence Number: 1669166
• Product Code: MCM
• UDI-Device Identifier: 09008737093976
• UDI-Public: (01)09008737093976
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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: Health Professional
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 09/19/2019
• 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: 12 YR