FDA.reportPublic FDA data

MAUDE MDR 4283569

MDR report key
4283569
Report number
1627487-2014-25680
Event key
0
Event type
3
Date of event
2014-10-27
Date received
2014-11-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
BENJYNA OBASUYI
Address
6901 PRESTON RD. PLANO TX 75024 US
Phone
972-972-9725
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BRIODBS IPGST. JUDE MEDICAL - NEUROMODULATIONIPG67883949170N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-11-2101. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THE PT'S (B)(6) IPG IS NOT COMMUNICATING WITH THE CLINICIAN OR PT PROGRAMMER AND CHARGER. ADDITIONALLY, IT IS UNK IF THE IPG AND CHARGER. ADDITIONALLY, IT IS UNK IF THE IPG COULD COMMUNICATE WITH THE PROGRAMMERS OR CHARGER PRIOR TO IMPLANT. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN TO EXPLANT AND REPLACE THE IPG.

N

Patient 1

THIS DEVICE IS NOT APPROVED FOR SALE IN THE US. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.