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

Model Number SONNET BATTERY PACK COVER [OPUS 3 BP COVER]

Device Problems Crack (1135); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the child lock has detached from the battery pack cover within a week of use.

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 Description

It was reported that the child lock has detached from the battery pack cover within a week of use.Reportedly, the same issue has also occurred with the previous cover.A new cover has been provided.

Manufacturer Narrative

Conclusion: according the information received, the child lock of the sonnet battery pack covers broken out.The device investigations revealed a damaged lock that was most likely caused by mechanical stress.This is a final report.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: 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: 15678229
• MDR Text Key: 302479349
• Report Number: 9710014-2022-00802
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SONNET BATTERY PACK COVER [OPUS 3 BP COVER]
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 22 MO
• Patient Sex: Female