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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
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
Loud voices are uncomfortable when they are near the implanted side.
Event or Problem Description
Affected channels have been observed during in situ testing.At a visit on the (b)(6) 2020, the user reported an off-sensation of the head, feeling soft and dizziness when wearing the device.However, on the (b)(6) 2020 the user's hearing was reportedly improving and the soft feeling and dizziness disappeared.Loud voices were uncomfortable.The user was re-implanted on (b)(6) 2020.The explanted device has not been returned for investigation purposes yet.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.However to determine an exact root cause a device investigation of the explanted device is necessary.Additionally, the recipient experienced dizziness and soft feeling when using the device in the first months after implantation, which then disappeared.Temporary dizziness and numbness are possible known undesired side-effects of cochlear implantation.The concerned device was explanted but has not been received for investigation yet.
Additional Manufacturer Narrative
Conclusions: damage to the active electrode, likely caused by minute device mobility, was determined to have led to device failure over time.Other damages found during device investigation are attributable to the removal surgery.Additionally, the recipient experienced dizziness and soft feeling when using the device in the first months after implantation, which then disappeared.Temporary dizziness and numbness are possible known undesired side-effcts of cochlear implantation.The problems given in the recipient report appear to match the damage found.This is a final report.
Event or Problem Description
Affected channels have been observed during in situ testing.At a visit on the 18th february 2020, the user reported an off-sensation of the head, feeling soft and dizziness when wearing the device.However, on the (b)(6) 2020 the user's hearing was reportedly improving and the soft feeling and dizziness disappeared.Loud voices were uncomfortable.The user was re-implanted on (b)(6) 2020.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.However to determine an exact root cause a device investigation of the explanted device is necessary.No date on possible re-implantation has been provided yet.This is a final report.
Event or Problem Description
Affected channels have been observed during in situ testing.Recipient did report that loud voices are uncomfortable when they are near the implanted side.The user will undergo a revision surgery, no date scheduled yet.

• 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: 10349056
• Report Number: 9710014-2020-00414
• Device Sequence Number: 2697673
• Product Code: MCM
• UDI-Device Identifier: 09008737366728
• UDI-Public: (01)09008737366728
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/07/2021

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: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 07/22/2020; 07/22/2020; 07/22/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 11/09/2020; 01/04/2021; 04/07/2021
• 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: 9 YR