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	Failure of Implant (1924); Undesired Nerve Stimulation (1980)
Date of Event	08/29/2019
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 was doing well since activation with performance increasing over time, however recently (b)(6) 2019 the sound with the device became too soft.The recipient now has 6 available channels, but during fitting those channels (ch.1-6) caused facial nerve stimulation and the stimulation levels were still too soft.Triphasic stimulation did not resolve stimulation of the facial nerve.
Additional Manufacturer Narrative
Conclusions: the returned available parts of the implant are working within specification during investigation and observed mechanical damages are attributable to the removal surgery.According to the available information, the recipient experienced facial nerve stimulation (fns) on multiple channels, which is a known possible post-operative side effect of cochlear implantation.In addition, few channels showed high impedance whilst implanted for undetermined reasons; the cause of the affected channels could not be determined as the electrode has not been received for investigation.Finally, three channels were left out of cochlea during implantation which might have been a contributory factor to the lack of benefit.This is a final report.
Event or Problem Description
Reportedly the sound with the device became too soft starting in august 2019.Prior the recipient was doing well with performance increasing over time.The recipient had 6 channels left for stimulation, but during most comfortable loudness measures the remaining channels (1-6) caused facial nerve stimulation and the levels were still too soft.Triphasic stimulation and re-fittings did not resolve stimulation of the facial nerve.Re-implantation took place on (b)(6), 2019.One week post activation there was an improvement in aided thresholds and the user reported improved clarity.The user reported the sound was initially too soft but after mapping an improvement in loudness and clarity was reported.

• 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: 8978934
• Report Number: 9710014-2019-00672
• Device Sequence Number: 3288407
• Product Code: MCM
• UDI-Device Identifier: 09008737094089
• UDI-Public: (01)09008737094089
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 05/12/2020
• 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: 16 YR