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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH BONEBRIDGE; BCI BONE CONDUCTION IMPLANT
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MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH BONEBRIDGE; BCI BONE CONDUCTION IMPLANT Back to Search Results
Model Number BCI601 BONE CONDUCTION IMPLANT
Medical Device Problem Code Output Problem (3005)
Health Effect - Clinical Code Failure of Implant (1924)
Type of Reportable Event Serious Injury
Event or Problem Description
The user's hearing performance with the device was affected.The user reported a shocking sensation around the implant site which also extends to her right ear and cheek.She reports this sensation with the audio processor (ap) in place and also when not wearing the ap.Re-implantation took place on (b)(6) 2021.This report refers to 9710014-2021-00473.For further information please refer to this report.
 
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Brand Name
BONEBRIDGE
Common Device Name
BCI BONE CONDUCTION IMPLANT
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
innsbruck
AU 
MDR Report Key12105884
Report Number1066702-2021-00053
Device Sequence Number11912263
Product Code PFO
UDI-Device Identifier09008738521805
UDI-Public(01)09008738521805
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P000025
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/02/2021
Report Date (Section F) 06/24/2021
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
Operator of Device Lay User/Patient
Device Model NumberBCI601 BONE CONDUCTION IMPLANT
Device Catalogue Number52180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2021
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/24/2021
Event Location Other
Date Report to Manufacturer06/24/2021
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age54 YR
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