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

Model Number	MI1000 MED-EL CONCERT PIN
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Type of Reportable Event	Malfunction
Event or Problem Description
On the (b)(6) 2021 the user experienced electric shocks from his implant while using his sonnet audio processor.The child was seen on (b)(6) 2021 by a med-el representative and there was no swelling, soreness, or redness above the implant site.A new audio processor program was created using his fully functional opus 2 audio processor.The user showed no signs of discomfort during fitting and afterwards for several hours.However, later the same day, the child again experienced an electric shock.Before the event occurred, the user has used his implant for more than 9 years.He had open set perception and highly intelligible speech.It is planned to re-implant the user.
Additional Manufacturer Narrative
Conclusion: device investigations did not reveal any device defect or problem.According to the recipient report the device was explanted due to pain and shocking sensation at the implant site.Reportedly, the symptoms also occurred without the audioprocessor on indicating a device unrelated issue.During removal surgery, a burning of the tissue, surrounding the implant body was reported.However, "pf18-992_30_heat dissipation of med-el sonatati100 mi1000 concerto (pin) mi1200 syn-chrony (pin) and mi1210 synchrony st during normal operation" proofs that heating of the internal device is technically impossible.This is a final report.
Event or Problem Description
On the (b)(6) 2021 the user experienced electric shocks from his implant while using his sonnet audio processor.He had severe pain around the implant site, the site heated up, he vomited and cried.A few hours later he tried to use his device again, however, after a few hours the same event happened again.His family was told to immediately remove the processor and not use it anymore.The child was seen on (b)(6) 2021 by a med-el representative and there was no swelling, soreness, or redness above the implant site.Before the event occurred, the user has used his implant for more than 9 years.He had open set perception and highly intelligible speech.There are no known medical conditions that might account for the reported symptoms.The magnet strength has been deemed adequate and there were no changes in the skin flap thickness.The recipient has been reimplanted.

• 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: 12687723
• Report Number: 9710014-2021-00819
• Device Sequence Number: 4165484
• Product Code: MCM
• UDI-Device Identifier: 09008737062712
• UDI-Public: (01)09008737062712
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 09/27/2022

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: 02/28/2013
• Device Model Number: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 07678
• 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: 10/21/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2011
• 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: 10 YR
• Patient Sex: Male