FDA.reportPublic FDA data

MAUDE MDR 7086759

MDR report key
7086759
Report number
MW5073759
Event key
0
Event type
3
Date of event
2017-11-28
Date received
2017-12-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AMS 700MS PUMPBOSTON SCIENTIFICPIH72401850625036009I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-0501. R

Event Narratives#

D

Patient 1

IMPLANTED DEVICE FROM 2009 FAILED.