FDA.reportPublic FDA data

MAUDE MDR 6624659

MDR report key
6624659
Report number
3007566237-2017-02268
Event key
0
Event type
3
Date of event
2017-04-14
Date received
2017-06-08
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
LISA WOODWARD CLARK
Address
7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDTRONIC NEUROMODULATIONMFRNEU_INS_STIMULATORNEU_INS_STIMULATORUNKNOWN* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-0801. R

Event Narratives#

N

Patient 1

PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

LIM, LH., NOMA FITZROL, D., RAJAPATHY, SK., TAN, YC., SANIHAH, AH., KANDASAMY, R., WAN HASSAN, WMN., BADRISYAH, I., ABDUL RAHMAN IZAINI, G., ZAMZURI, I., THARAKAN, J., NUNTA-AREE, S., JAFRI MALIN, A. DEEP BRAIN STIMULATION (DBS) FOR MOVEMENT DISORDERS: AN EXPERIENCE IN HOSPITAL UNIVERSITI SAINS MALAYSIA (HUSM) INVOLVING 12 PATIENTS. MALAYSIAN JOURNAL OF MEDICAL SCIENCES. 2017;24(2):87-93. DOI: 10.21315/MJMS2017.24.2.11. SUMMARY: DEEP BRAIN STIMULATION (DBS) WAS FIRST INTRODUCED IN 1987 TO THE DEVELOPED WORLD. AS A DEVELOPING COUNTRY MALAYSIA BEGUN ITS MOVEMENT DISORDER PROGRAM BY DOING ABLATION THERAPY USING THE RADIONICS SYSTEM. HOSPITAL UNIVERSITI SAINS MALAYSIA A RURAL BASED TEACHING HOSPITAL HAD TO TAKE INTO CONSIDERATION BOTH HEALTH ECONOMICS AND OUTCOMES IN THE AREA THAT IT WAS PROVIDING NEUROSURGICAL CARE FOR WHEN IT INITIATED ITS DEEP BRAIN STIMULATION PROGRAM. MOST OF THE PATIENTS WERE FROM THE LOW TO MEDIUM SOCIAL ECONOMIC GROUPS AND COULD NOT AFFORD PAYMENT FOR A DBS IMPLANT. WE CONCENTRATED OUR DBS SERVICES TO PARKINSON'S DISEASE, TOURETTE'S SYNDROME AND DYSTONIA PATIENTS WHO HAD EXHAUSTED MEDICAL THERAPY. THE CASE SERIES OF THESE PATIENTS AND THEIR FOLLOW-UP ARE PRESENTED IN THIS BRIEF COMMUNICATION. REPORTED EVENTS: 1. CASE 12: A (B)(6) MALE WITH DEEP BRAIN STIMULATION (DBS) OF THE MEDIAL THALAMUS FOR TOURETTE?S SYNDROME EXPERIENCED AN ALLERGIC REACTION TO THE DEVICE SHORTLY AFTER IMPLANT SO THE DEVICE WAS REMOVED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.