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

Model Number MI1000 MED-EL CONCERT PIN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 08/02/2023

Event Type  malfunction  

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 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.

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 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.

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 320699851
• Report Number: 9710014-2023-00674
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female