FDA.reportPublic FDA data

MAUDE MDR 9908714

MDR report key
9908714
Report number
3006630150-2020-01569
Event key
0
Event type
3
Date of event
2020-03-12
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
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
1SPECTRA WAVEWRITERSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEFBOSTON SCIENTIFIC NEUROMODULATIONLGWSC-1160SC-1160344610R N

Patients#

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

Event Narratives#

N

Patient 1

MODEL NUMBER/ CATALOG NUMBER: SC-2208-50, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 188544, MODEL/ CATALOG DESCRIPTION: ST LINEAR LEAD 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

D

Patient 1

A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.