FDA.reportPublic FDA data

MAUDE MDR 9885528

MDR report key
9885528
Report number
3006556115-2020-00161
Event key
0
Event type
3
Date of event
2020-03-12
Date received
2020-03-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
BROOKE LOPEZ
Address
28515 WESTINGHOUSE PLACE VALENCIA CA 91355 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HIRES 90K? IMPLANTCOCHLEAR IMPLANTADVANCED BIONICS, LLCMCMCI-1400-01NANAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2601. R

Event Narratives#

D

Patient 1

THE RECIPIENT REPORTEDLY EXPERIENCED SKIN FLAP BREAKDOWN AT THE IMPLANT SITE, WHICH LED TO DEVICE EXTRUSION. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE ON THE CONTRALATERAL SIDE. THE RECIPIENT DID NOT RECEIVE MEDICAL INTERVENTION PRIOR TO EXPLANTATION.