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]

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to innsbruck where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.

Event Description

The device has been received at service repair and a leaking battery was discovered.According to the repair request form there have been sound quality issues.

Event Description

The device has been received at service repair and a leaking battery was discovered.According to the repair request form there have been sound quality issues.

Manufacturer Narrative

Conclusion: the complaint was opened during a normal repair process after a leaking rechargeable battery was detected.A broken welding seam at the housing was found.The rechargeable battery housing is broken and covered with leaking electrolyte, which was also located around the destroyed electrical components.It is reported that the user did not come into contact with any electrolyte fluid.However, it is assumed that the device got damaged due to excessive mechanical forces.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
• MDR Report Key: 10452730
• MDR Text Key: 204345933
• Report Number: 9710014-2020-00464
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737304591
• UDI-Public: (01)09008737304591
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RONDO PROCESSOR 2 [BUTTON PROCESSOR 2]
• Device Catalogue Number: 30459
• Device Lot Number: 30459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR