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

Model Number	RONDO PROCESSOR 2 [BUTTON PROCESSOR 2]
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The family of the user reported that the magnet of the rondo 2 was channeled up and cracked the housing.The magnet is stuck and cannot be removed.Reportedly, the user did not fall or fall on the device and is handling the device as instructed.Additionally, the device runs out of battery quickly.A temporarily loaner device was provided to the user.
Additional Manufacturer Narrative
Conclusion: according the information received, the magnet of the rondo 2 was channeled up and cracked the housing.The magnet is stuck and cannot be removed.The investigation revealed severe damages to the magnet and the housing, indicating leverage exerted and improper handling.Additionally, leaking electrolyte was observed and it cannot be ruled out that leaking electrolyte has escaped from the housing.However, since the internal battery is located in a silicone protector, it can be ruled out that the observed damage was caused from the inside.Furthermore, a leaking electrolyte is not capable of damaging the plastic of the housing.Several damages indicate a strong mechanical stress on the device.This is a combined initial and final report.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: EXTERNAL COMPONENT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 12922320
• Report Number: 9710014-2021-00967
• Device Sequence Number: 4994583
• Product Code: MCM
• UDI-Device Identifier: 09008737304591
• UDI-Public: (01)09008737304591
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2021

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 Model Number: RONDO PROCESSOR 2 [BUTTON PROCESSOR 2]
• Device Catalogue Number: 30459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 8 YR
• Patient Sex: Male