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

Model Number	RONDO 2 AUDIO PROCESSOR [BUTTON PROCESSOR 2]
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
Event or Problem Description
The rondo 2 was returned to service and repair due to welding seam being broken.Upon preliminary inspection at service it was confirmed the housing was opened and the rechargeable battery inside was leaking.
Additional Manufacturer Narrative
Conclusion: during the repair process of a rondo 2 audio processor a leaking battery was detected.The electrolyte corroded the silicon sleeve of the battery.The damage to the coil and the rechargeable battery inside is most likely caused due to strong mechanical stress.This is a final report.
Event or Problem Description
The rondo 2 was returned to service and repair due to welding seam being broken.Upon preliminary inspection at service it was confirmed the housing was opened and the rechargeable battery inside was leaking.

• 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: 17743732
• Report Number: 9710014-2023-00815
• Device Sequence Number: 4184487
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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 2 AUDIO PROCESSOR [BUTTON PROCESSOR 2]
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 18 MO
• Patient Sex: Male