FDA.reportPublic FDA data

MAUDE MDR 9908139

MDR report key
9908139
Report number
2183959-2020-01770
Event key
0
Event type
3
Date of event
2019-09-23
Date received
2020-03-31
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
ALYSON HARRIS
Address
10700 BREN ROAD W MINNETONKA MN 55343 US
Phone
408-408-4089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AMS 800 URINARY CONTROL SYSTEMDEVICE INCONTINENCE MECHANICAL/HYDRAULICBOSTON SCIENTIFIC CORPORATIONEZYUNK-P-AUSUNK-P-AUSR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. H; 2. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PERSISTENT/RECURRING INCONT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS). THE AUS CUFF, PUMP, AND BALLOON WAS EXPLANTED AND A NEW AUS CUFF, PUMP, AND BALLOON WAS IMPLANTED. THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE.