FDA.reportPublic FDA data

MAUDE MDR 9392193

MDR report key
9392193
Report number
1627487-2019-12784
Event key
0
Event type
3
Date of event
2019-10-21
Date received
2019-11-30
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
ANDREA DEITZ
Address
6901 PRESTON ROAD PLANO TX 75024 US
Phone
972-972-9723
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AXIUM 50CM IMPLANT LEAD KIT, SLIMTIPDRG LEADST. JUDE MEDICAL - NEUROMODULATIONPMPMN10450-50AAB2222R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-3001. O

Event Narratives#

No narrative records found.