FDA.reportPublic FDA data

MAUDE MDR 9832755

MDR report key
9832755
Report number
3006630150-2020-01185
Event key
0
Event type
3
Date of event
2020-02-21
Date received
2020-03-14
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
TALAR TAHMASIAN
Address
25155 RYE CANYON LOOP VALENCIA CA 91355 US
Phone
661-661-6619
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BOSTON SCIENTIFIC NEUROMODULATIONNHLR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1401. R

Event Narratives#

N

Patient 1

THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

D

Patient 1

A REPORT WAS RECEIVED THAT THE PATIENTS IPG WOULD NOT HOLD ITS CHARGE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE.