BONEBRIDGE BCI601 BONE CONDUCTION IMPLANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-07 for BONEBRIDGE BCI601 BONE CONDUCTION IMPLANT manufactured by Med-el Elektromedizinische Geraete Gmbh.

Event Text Entries

[153675383] The device has not been explanted. If it should be explanted, it is to be returned to the manufacturer for evaluation. When available, a device failure analysis will be submitted as a follow up report.
Patient Sequence No: 1, Text Type: N, H10


[153675384] The user has no longer auditory sensation with the device unless pressing the audio processor firmly onto the implant. The external parts were checked and no problems were reported. The magnet strength for the audio processor is 4, and a 7 (5+2) strength magnet was also tried but the issues remained. There is no problem with the adhesion of the audio processor to the implant. The device is currently not in use and the recipient is currently wearing a bone conduction hearing aid. Re-implantation has been suggested by vibrant clinical support.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710014-2019-00600
MDR Report Key8868900
Date Received2019-08-07
Date of Report2019-08-07
Date of Event2019-04-01
Date Mfgr Received2019-08-06
Date Added to Maude2019-08-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLAURA SIMONOTTI
Manufacturer StreetFUERSTENWEG 77A
Manufacturer CityINNSBRUCK 6020
Manufacturer CountryAU
Manufacturer Postal6020
Manufacturer Phone57788
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBONEBRIDGE
Generic NameBCI BONE CONDUCTION IMPLANT
Product CodeMPV
Date Received2019-08-07
Model NumberBCI601 BONE CONDUCTION IMPLANT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
Manufacturer AddressINNSBRUCK AU


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-07

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