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 Codes	Fluid/Blood Leak (1250); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been 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 reported that the device has an issue with holding its charge and that the battery life is short.Furthermore, they discovered a gel-like leakage on the surface of the magnet.The user was not injured by any leakage.The device will be sent to hq.
Additional Manufacturer Narrative
Conclusion: according to the information received, the battery life of the rondo 2 audio processor was short and a "gel-like" leakage was discovered.The investigation revealed that the battery capacity was out of specification, explaining the battery issues, however no leakage of the battery was observed during device investigation.This is a final report.
Event or Problem Description
The user reported that the device has an issue with holding its charge and that the battery life is short.Furthermore, they discovered a gel-like leakage on the surface of the magnet.The user was not injured by any leakage.

• 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: 16968187
• Report Number: 9710014-2023-00422
• Device Sequence Number: 5491642
• Product Code: MCM
• UDI-Device Identifier: 09008737304591
• UDI-Public: (01)09008737304591
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 06/20/2023

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 Model Number: RONDO PROCESSOR 2 [BUTTON PROCESSOR 2]
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown