VIBRANT SOUNDBRIDGE VORP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-25 for VIBRANT SOUNDBRIDGE VORP manufactured by Med-el Elektromedizinische Geraete Gmbh.

Event Text Entries

[180721178] The device has been explanted and should 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


[180721179] The user visited the hospital after suddenly losing access to sound with the device. There is no report of any accident or trauma. The recipient was reimplanted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710014-2020-00125
MDR Report Key9749655
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-25
Date of Report2020-02-25
Date of Event2020-01-15
Date Mfgr Received2020-02-18
Date Added to Maude2020-02-25
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 Received2020-02-25
Model NumberVORP
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
Manufacturer AddressINNSBRUCK AU


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-25

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