VIBRANT SOUNDBRIDGE VORP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-16 for VIBRANT SOUNDBRIDGE VORP manufactured by Med-el Elektromedizinische Geraete Gmbh.

Event Text Entries

[142051834] 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


[142051835] The user reported that she was no longer able to hear with the device. This loss of sound was sudden. There is no report of any trauma or illness. Re-implantation is considered.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710014-2019-00329
MDR Report Key8517755
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-04-16
Date of Report2019-05-29
Date Mfgr Received2019-04-12
Date Added to Maude2019-04-16
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 Report3

Device Details

Brand NameVIBRANT SOUNDBRIDGE
Generic NameMIDDLE EAR IMPLANT
Product CodeMPV
Date Received2019-04-16
Model NumberVORP
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
Manufacturer AddressINNSBRUCK AU


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-16

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