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 Problems Fluid/Blood Leak (1250); Output Problem (3005)

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

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to (b)(4) where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.

Event Description

During the normal repair process a leaking rondo 2 rechargeable battery was discovered.According to the repair request form, the device was sent for repair due to not being functional.The user confirmed that she did not notice any leaking electrolytic fluid or come into contact with any fluid.No injury was sustained.

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 and oxidized a few traces in the uppermost part of the circuit board array.Measurement failed due to the microphone being out of specification.Also the welding seam is broken.The damage to the housing and the rechargeable battery inside is most likely caused due to mechanical stress.This is a final report.

Event Description

During the normal repair process a leaking rondo 2 rechargeable battery was discovered.According to the repair request form, the device was sent for repair due to not being functional.The user confirmed that she did not notice any leaking electrolytic fluid or come into contact with any fluid.No injury was sustained.

• 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: 10747391
• MDR Text Key: 213444632
• Report Number: 9710014-2020-00613
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR