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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Implant Pain (4561); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been explanted and 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
The user has experienced no benefit with the device since the last revision surgery that took place on the (b)(6) 2018.The user is also suffering from an infection and from pain, which led to explantation.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or malfunction which is expected to have been present whilst implanted.Based on the received information from the field, the user suffers from chronic and recurrent ear disease, including otitis media, mastoiditis and cholesteatoma.A revision surgery without implant removal was conducted, however, total eradication of the ear disease was unsuccessful and infection of the mastoid cavity re-occurred, but without involvement of the implant site.Possible complications of cholesteatoma removal surgeries include: accumulation of epithelial debris in the cavity and necrosis of its cutaneous layer, with subsequent electrode migration, as observed in the present case.A further, but rare, complication of chronic infection and in particular cholesteatoma is represented by erosion of the cochlea.In such case, no hearing perception can be achieved.A review of the device's sterilization records shows that the device has been subject to a valid sterilization process.No information points to a device contribution to the reported problems, which are most likely a consequence of the above mentioned chronic ear pathology.Minor mechanical damages found during investigation are attributable to the removal surgery.This is a final report.
Event or Problem Description
The user has experienced no benefit with the device since the last revision surgery that took place on the (b)(6) 2018 and is also suffering from an infection and from pain, which led to explantation.The revision surgery was a tympanomastoid-revsision without ci explantation.There are no plans to reimplant the user, because the infection has damaged the cochlea.According to the explant report form 6 channels were found extra-cochlea at explantation.

• 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: 12075832
• Report Number: 9710014-2021-00470
• Device Sequence Number: 14293285
• Product Code: MCM
• UDI-Device Identifier: 09008737094027
• UDI-Public: (01)09008737094027
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 11/02/2020
• Device Model Number: MI1200 SYNCHRONY
• Device Catalogue Number: 31091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 08/17/2021
• 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: 69 YR