Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; EXTERNAL COMPONENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; EXTERNAL COMPONENT Back to Search Results
Model Number SONNET 2 CONTROL UNIT [OPUS 4 CPU]
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 zinc air batteries were swelling in the battery pack frame of the external device so that the battery pack cover was damaged.Both parts were replaced by the care center but after replacing the batteries the same event happened again and the batteries were swelling in the battery pack again.There was leaking electrolyte observed, however the user did not sustain any injuries.
 
Manufacturer Narrative
Conclusion: according to the information received, a zinc-air battery has blown up and damaged the battery pack covers.Investigation conducted on the concerned devices found signs of usage and also mechanical damage attributable to the zinc air battery expansion.However, the audio processor and battery pack frame are still electrically functional.The observed expansion was therefore most likely caused by a defective zinc air battery.The recipient did not get injured due to this issue.This is a final report.
 
Event Description
It was reported that the zinc air batteries were swelling in the battery pack frame of the external device so that the battery pack cover was damaged.Both parts were replaced by the care center but after replacing the batteries the same event happened again and the batteries were swelling in the battery pack again.There was leaking electrolyte observed, however the user did not sustain any injuries.Sonnet 2 speech processor has been exchanged.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event 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 Key16068610
MDR Text Key306414094
Report Number9710014-2022-00993
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09008737349332
UDI-Public(01)09008737349332
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/16/2023
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 NumberSONNET 2 CONTROL UNIT [OPUS 4 CPU]
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/28/2022
Initial Date FDA Received12/29/2022
Supplement Dates Manufacturer Received12/28/2022
Supplement Dates FDA Received03/16/2023
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 Number1
Patient Age12 YR
Patient SexFemale
-
-