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

Model Number	SONNET 2 CONTROL UNIT [OPUS 4 CPU]
Medical Device Problem Code	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
It was reported that the zinc air batteries were swelling in the battery pack frame of the external device so that the battery pack cover was damaged.Both parts were replaced by the care center but after replacing the batteries the same event happened again and the batteries were swelling in the battery pack again.There was leaking electrolyte observed, however the user did not sustain any injuries.
Additional Manufacturer Narrative
Conclusion: according to the information received, a zinc-air battery has blown up and damaged the battery pack covers.Investigation conducted on the concerned devices found signs of usage and also mechanical damage attributable to the zinc air battery expansion.However, the audio processor and battery pack frame are still electrically functional.The observed expansion was therefore most likely caused by a defective zinc air battery.The recipient did not get injured due to this issue.This is a final report.
Event or Problem Description
It was reported that the zinc air batteries were swelling in the battery pack frame of the external device so that the battery pack cover was damaged.Both parts were replaced by the care center but after replacing the batteries the same event happened again and the batteries were swelling in the battery pack again.There was leaking electrolyte observed, however the user did not sustain any injuries.Sonnet 2 speech processor has been exchanged.

• 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: 16068610
• Report Number: 9710014-2022-00993
• Device Sequence Number: 15009528
• Product Code: MCM
• UDI-Device Identifier: 09008737349332
• UDI-Public: (01)09008737349332
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/16/2023

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: SONNET 2 CONTROL UNIT [OPUS 4 CPU]
• 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: 12/28/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 03/16/2023
• 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: 12 YR
• Patient Sex: Female