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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Code	Migration (4003)
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 underwent a repositioning surgery at the beginning of (b)(6) 2022 due to movement of the implant towards the pinna.Reportedly, the user then put on his audio processor and reported a fuzzy sound quality.A ct is planned to confirm the placement.
Event or Problem Description
In (b)(6) 2021 the user reported that the device moved towards the pinna after chronically rubbing over the implant site.The user underwent a repositioning surgery at the beginning of (b)(6) 2022 to position the device more posteriorly.After the surgery, when the audio processor was put on again, fuzzy sound quality was reported.A ct scan showed that a portion of the array was out of the cochlea.Displacement of the array occurred post-revision surgery.The user underwent a second revision surgery on the (b)(6) 2022.
Additional Manufacturer Narrative
Additional information: according to the information received from the field, the implant housing migrated from its intended position and the recipient underwent a revision surgery to re-position the device.Reportedly, the recipient repeatedly rubbed over the implant area, which might have induced the misplacement in combination with insufficient fixation.After the revision surgery the electrode array partially migrated out of cochlea as confirmed with diagnostic imaging.Another revision surgery was performed successfully to re-insert the electrode, during which tissue growth in the facial recess was found, that likely contributed to the observed electrode migration.The device remains implanted and in use.
Event or Problem Description
In december 2021 the user reported that the device moved towards the pinna after chronically rubbing over the implant site.The user underwent a repositioning surgery at the beginning of (b)(6) 2022 to position the device more posteriorly.After the surgery, when the audio processor was put on again, fuzzy sound quality was reported.On the (b)(6) 2022 at programming after the first revision surgery, the user had no hearing perception on channels 7-11 but a pulsation could be felt over the entire head with stimulation.The user underwent a second revision surgery on the (b)(6) 2022.The surgeon reported significant scar tissue growth in the mastoid cavity and facial recess as well as excessive bony growth around the facial recess.The user was seen again on the (b)(6) 2022 for programming after second the revision and was doing well with the repositioned device.On the (b)(6) 2022 it was reported that there has been decreasing sound quality since the last appointment.The quality is becoming more and more tinny.There is concern that the electrode is backing out again, but the surgeon is not planning to do a repeat ct at this time and the user will be monitored.
Additional Manufacturer Narrative
Additional information: according to the information received from the field, the implant housing migrated from its intended position and the recipient underwent a revision surgery to re-position the device.Reportedly, the recipient repeatedly rubbed over the implant area, which might have induced the misplacement in combination with insufficient fixation.After the revision surgery the electrode array partially migrated out of cochlea as confirmed with diagnostic imaging.Another revision surgery was performed successfully to re-insert the electrode, during which tissue growth in the facial recess was found, that likely contributed to the observed electrode migration.As per additional information received, some basal channels show high status due to undetermined reasons and were disabled.Also, following this second revision surgery, the recipient has reported decreasing sound quality since re-activation and there is concern of further migration.However, the recipient will be monitored by the clinic and the device remains implanted.
Event or Problem Description
The user was implanted in (b)(6) 2020 and the hearing performance with the device was as expected.However, in (b)(6) 2021 the user reported that the device moved towards the pinna after chronically rubbing over the implant site.The user underwent a repositioning surgery at the beginning of (b)(6) 2022 to position the device more posteriorly.After the surgery, when the audio processor was put on again, fuzzy sound quality was reported.A ct scan from (b)(6) 2022 showed that a portion of the array was out of the cochlea.Displacement of the array occurred post-revision surgery, because at revision surgery the surgeon confirmed before closing there were no extra-cochlear contacts.The user underwent a second revision surgery on the (b)(6)2022.The surgeon reported significant scar tissue growth in the mastoid cavity and facial recess as well as excessive bony growth around the facial recess.The user was seen again on the (b)(6)2022 for programming after the second revision and was doing well with the repositioned device.On the (b)(6)2022 it was reported that there had been decreasing sound quality since the last appointment.The quality became more and more tinny.As of information received on the (b)(6)2022, the electrode migrated further and 5 channels were disabled.Therefore, the user was re-implanted.Electrode array migration was confirmed, but the implant itself was solid and there was no rocking when pressed on it.During the surgery a significant amount of bone growth was seen which made explanting the device difficult.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received from the field, the implant housing initially migrated from its intended position and the recipient underwent a revision surgery to re-position the device.Reportedly, the recipient repeatedly rubbed over the implant area, which might have induced the misplacement in combination with insufficient fixation.After the revision surgery the electrode array partially migrated out of cochlea as confirmed with diagnostic imaging.Another revision surgery was performed successfully to re-insert the electrode, during which tissue growth in the facial recess was found, that likely contributed to the observed electrode migration.Finally, the device was explanted due to a re-occuring migration of the active electrode out of cochlea.Information on the device explantation report form states that five channels were found extra-cochlear.This is a final report.

• 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: 13420777
• Report Number: 9710014-2022-00077
• Device Sequence Number: 4676174
• Product Code: MCM
• UDI-Device Identifier: 09008737366773
• UDI-Public: (01)09008737366773
• 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: 2020
• 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,Followup
• Report Date (Section B): 09/22/2022

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: 11/14/2022
• Device Model Number: MI1250 SYNCHRONY 2 PIN
• Device Catalogue Number: 36706
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 01/25/2022; 01/25/2022; 01/25/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/17/2022; 05/10/2022; 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2019
• 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: 61 YR
• Patient Sex: Male