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

Model Number OPUS 2 CONTROL UNIT [T++ CPU]

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

The power pack cannot be returned to the manufacturer due to iata shipping restrictions.When available, a failure analysis will be submitted as a follow up report.

Event Description

The user's dacapo power pack overheated at school.Reportedly, the unit became very hot, smoked and leaked.The user was wearing the opus 2, d coil, dacapo battery frame and dacapo battery and the only part to heat up was the dacapo frame.The user has been advised to stop using the dacapo battery and frame.

Manufacturer Narrative

Conclusion: the investigation revealed on the opus 2 control unit and dacapo frame signs of electrical short circuits, which are most likely the reason for the reported issue.This may have been caused by a transient low impedance connection, most likely due to excessive moisture accumulation, humidity and/or sweat.Signs of moisture have been confirmed by investigation on the dacapo frame and control unit.Other findings detected during the investigation does not explain the reported symptom.This is a final report.

Event Description

The user reported that the dacapo power pack overheated at school.Reportedly, the unit became very hot, smoked and leaked.The user was wearing the opus 2, d coil, dacapo battery frame and dacapo battery and reportedly the only part to heat up was the dacapo frame.The user did not make contact with the leaking electrolyte and did not sustain any injuries from this event.This was the first time the user experienced these problems.The uv dryer is used on a daily basis and all parts are placed in the dryer individually.

• 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: 9514531
• MDR Text Key: 174681117
• Report Number: 9710014-2019-00978
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/07/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: OPUS 2 CONTROL UNIT [T++ CPU]
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 05/07/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 17 YR