FDA.reportPublic FDA data

MAUDE MDR 9890655

MDR report key
9890655
Report number
3006630150-2020-01475
Event key
0
Event type
3
Date of event
2019-09-04
Date received
2020-03-27
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
1NASTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMORBOSTON SCIENTIFIC NEUROMODULATIONMHYDB-2201-45DCDB-2201-45DC678910R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2701. R

Event Narratives#

N

Patient 1

ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL: DB-2201-45DC, SERIAL/LOT: (B)(4), DESCRIPTION: LEAD KIT 45CM.

D

Patient 1

A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED HIGH IMPEDANCES ON SEVERAL CONTACTS. HOWEVER, THE CONTACTS WITH HIGH IMPEDANCES WERE TURNED OFF AND OTHER CONTACTS WERE USED INSTEAD. THE PATIENT ALSO EXPERIENCED A BURNING SENSATION IN THEIR FEET FOR ABOUT TWENTY DAYS. PRIOR TO THE IMPLANT PROCEDURE, THE PATIENT COULD NOT MOBILIZE DUE TO A HIGH DEGREE OF STIFFNESS, WHICH RESULTED IN THE PATIENT HAVING COMPLETE DEPENDENCE ON OTHER PEOPLE. AFTER THE IMPLANT PROCEDURE, THE PATIENT CONTINUES TO HAVE A HIGH LEVEL OF STIFFNESS BUT IS ABLE TO WALK WITHOUT THE HELP OF OTHERS. IN ADDITION, THE PATIENT EXPRESSED THAT SINCE THE IMPLANT PROCEDURE, HE FEELS VERY ANXIOUS AND CANNOT SLEEP MORE THAN ONE HOUR DESPITE TAKING MEDICATION. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND SHOWED THE DISPLACEMENT OF THE RIGHT LEAD, LOCATED IN THE FRONTAL PART OF THE BRAIN, AND THE LEFT LEAD IN THE GLOBUS PALLIDUS INTERNUS (GPI). SINCE THE PATIENTS RESPONSE TO THE CHANGES IN THERAPY WERE NOT EFFECTIVE, THE PHYSICIAN DECIDED TO TURN OFF THE DEVICE. THE PATIENT THEN UNDERWENT A REVISION PROCEDURE TO EXPLANT THE ENTIRE SYSTEM. THE PATIENT IS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY.