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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Codes	Circuit Failure (1089); Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
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
The user began exhibiting concerns with right implant about 2 weeks ago (b)(6) 2022).First, the user threw and broke the primary processor, so the family started using the back up processor.It worked fine for a couple of days, then the dl-coil began intermittently flashing red while on the head, which then became a constant red flash.Mother reportedly replaced all external components, but the dl-coil flashing persisted.Since the child was exhibiting no signs of hearing from the implant they discontinued use of the processor on that side.
Additional Manufacturer Narrative
Additional information: based on the received information and in-situ measurements, a damage of the stimulator housing following an external impact to the device appears possible.Reportedly, the recipient does fall often and the audiologist noticed some swelling near right mastoid.In addition, previous situ measurements have shown few channels with high status due to undetermined reasons.However, to determine and confirm an exact root cause of failure a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
The user began exhibiting concerns with right implant in (b)(6) 2022.First, the user threw and broke the primary processor, so the family started using the back-up processor.It worked fine for a couple of days, then the dl-coil began intermittently flashing red while on the head, which then became a constant red flash.Mother reportedly replaced all external components, but the dl-coil flashing persisted.Since the child was exhibiting no signs of hearing from the implant they discontinued use of the processor on that side.Reportedly the user will be re-implanted but no date has been set yet.
Additional Manufacturer Narrative
Conclusion: the device investigation revealed mechanical damage to the stimulator electronics substrate that is typical for severe external impact to the housing.Reportedly, the recipient does fall often and the audiologist noticed some swelling near right mastoid.In addition, previous in situ measurements have shown a few channels with high status due to undetermined reasons.The investigation results appear to match the problems mentioned in the patient report.This is a final report.
Event or Problem Description
The user began exhibiting concerns with right implant in (b)(6) 2022.First, the user threw and broke the primary processor, so the family started using the back-up processor.It worked fine for a couple of days, then the dl-coil began intermittently flashing red while on the head, which then became a constant red flash.Mother reportedly replaced all external components, but the dl-coil flashing persisted.Since the child was exhibiting no signs of hearing from the implant they discontinued use of the processor on that side.The user was re-implanted.

• 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: 13928058
• Report Number: 9710014-2022-00232
• Device Sequence Number: 11191020
• Product Code: MCM
• UDI-Device Identifier: 09008737395407
• UDI-Public: (01)09008737395407
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2023

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 Expiration Date: 09/14/2023
• Device Model Number: MI1250 SYNCHRONY 2 PIN
• Device Catalogue Number: 39568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 03/23/2022; 03/23/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 05/16/2022; 02/22/2023
• 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: 4 YR
• Patient Sex: Male