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

Model Number SONNET RECHARGEABLE BATTERY [OPUS 3 RB]

Device Problems Crack (1135); Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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 Description

A broken sonnet rcb has been received at hq.Upon preliminary investigation by service repair, there was no leaking electrolyte observed.

Manufacturer Narrative

Conclusion: the returned device was visually inspected upon arrival.A mechanically damaged housing was observed, most likely due to external mechanical stress.The observed damage did not allow electrical testing to be conducted.The damage to the battery housing was clearly the reason for the malfunction of the device returned by the end-user.Despite requested no further information could be retrieved from the field.This is a final report.

Event Description

A broken sonnet rcb has been received at hq.Upon investigation by service repair there was no leaking electrolyte observed.

• 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: 16251890
• MDR Text Key: 308253840
• Report Number: 9710014-2023-00062
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SONNET RECHARGEABLE BATTERY [OPUS 3 RB]
• Device Lot Number: SN: 2107N074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1