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 Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	08/02/2023
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 contacted audiology technical support after having a contraindicated mri done on (b)(6) 2023.The processor magnet reportedly repelled from the internal magnet and abnormal sound quality and sensation were experienced.The user sent to med-el the mri report that showed that a 3.0t mri was performed and there was no headwrap.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient experienced magnet retention issue after magnetic resonance imaging (mri) performed at 3.0 tesla likely due to a demagnetization of the implant magnet.The instructions for use (ifu) for the concerned device clearly state that the concerned device is mri conditional for scanner field strengths of 0.2 tesla, 1.0 tesla and 1.5 tesla.Therefore the performed mri examination constitutes an abnormal use.Revision surgery is planned in (b)(6) 2023.
Event or Problem Description
The user contacted audiology technical support after having a contraindicated mri done on (b)(6) 2023.She denied pain or discomfort during the mri but when she got home, she reported the processor magnet repelled from the internal magnet.When she tried to wear it, she experienced an abnormal sound quality and sensation.The user sent med-el the mri report that showed that a 3.0 t mri was performed and there was no head-wrap.The user has decided to go ahead with revision surgery, it is likely to take place in (b)(6) 2023.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the recipient experienced magnet retention issue after magnetic resonance imaging (mri) performed at 3.0 tesla likely due to a demagnetization of the implant magnet.Device investigation confirmed a de-magnetized magnet.Other mechanical damages found are attributable to the removal surgery.The instructions for use (ifu) for the concerned device clearly state that the concerned device is mri conditional for scanner field strengths of 0.2 tesla, 1.0 tesla and 1.5 tesla.Therefore the performed mri examination constitutes an abnormal use.This is a final report.Correction to previous report: required intervention "yes".
Event or Problem Description
The user contacted audiology technical support after having a contraindicated mri done on (b)(6) 2023.The user denied pain or discomfort during the mri but when she got home, she reported the processor magnet repelled from the internal magnet.When she tried to wear it, she experienced an abnormal sound quality and sensation.The user sent med-el the mri report that showed that a 3.0 t mri was performed and there was no head-wrap.The user has been reimplanted on (b)(6)2023.
Event or Problem Description
The user contacted audiology technical support after having a contraindicated mri done on (b)(6) 2023.The user denied pain or discomfort during the mri but when she got home, she reported the processor magnet repelled from the internal magnet.When she tried to wear it, she experienced an abnormal sound quality and sensation.The user sent med-el the mri report that showed that a 3.0 t mri was performed and there was no head-wrap.The user has been reimplanted on (b)(6)2023.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the recipient experienced magnet retention issue after magnetic resonance imaging (mri) performed at 3.0 tesla likely due to a demagnetization of the implant magnet.Device investigation confirmed a de-magnetized magnet.Other mechanical damages found are attributable to the removal surgery.The instructions for use (ifu) for the concerned device clearly state that the concerned device is mri conditional for scanner field strengths of 0.2 tesla, 1.0 tesla and 1.5 tesla.Therefore the performed mri examination constitutes an abnormal use.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: 17457175
• Report Number: 9710014-2023-00674
• Device Sequence Number: 7236993
• Product Code: MCM
• UDI-Device Identifier: 09008737083625
• UDI-Public: (01)09008737083625
• 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: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/28/2024

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: 07/01/2014
• Device Model Number: MI1000 MED-EL CONCERT PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 08/02/2023; 08/02/2023; 08/02/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 09/12/2023; 02/27/2024; 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2012
• 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: 59 YR
• Patient Sex: Female