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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
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MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; EXTERNAL COMPONENT Back to Search Results
Model Number ZINC AIR BATTERIES
Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2020
Event Type  malfunction  
Manufacturer Narrative
When available, a device failure analysis will be submitted as a follow up report.
 
Event Description
The zinc air batteries (varta power one implant plus 675) were used in both the bilateral user's sonnet audioprocessors.After some time, the user heard a loud pop noise in both processors.When the battery pack covers were opened it was noted that 1 battery in each sonnet was swollen looking.The user bought the batteries into the local service center and whilst they were being checked the swollen batteries exploded.No injuries occurred and the user did not come into contact with battery electrolyte.
 
Manufacturer Narrative
Conclusion: concerned batteries could not be retrieved for investigation.Based on information received, it could be initially assumed that one battery shorted into the sonnet battery pack frame, likely due to sweat or humidity, and gassed inside leading to its expansion.However, the investigation found minor signs of corrosion in only one of the two received sonnet battery pack frames.Furthermore, the batteries were reportedly not exposed to moisture.Therefore, a defective battery seems likely.This is a final report.
 
Event Description
The zinc air batteries (varta power one implant plus 675) were used in both the bilateral user's sonnet audioprocessors.After some time, the user heard a loud pop noise in both processors.When the battery pack covers were opened it was noted that 1 battery in each sonnet was swollen looking.The user bought the batteries into the local service center and whilst they were being checked the swollen batteries exploded.No injuries occurred and the user did not come into contact with battery electrolyte.
 
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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 Key10223323
MDR Text Key197781494
Report Number9710014-2020-00347
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
PMA/PMN Number
P000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberZINC AIR BATTERIES
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age6 YR
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