FDA.reportPublic FDA data

MAUDE MDR 6538203

MDR report key
6538203
Report number
3007566237-2017-01686
Event key
0
Event type
3
Date of event
2017-01-23
Date received
2017-05-02
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
1ACTIVASTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMORMEDTRONIC NEUROMODULATIONMFR3760137601UNKNOWN* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-0201. O

Event Narratives#

N

Patient 1

NOTE, THIS EVENT WAS PREVIOUSLY REPORTED UNDER 3007566237-2013-02552 UNTIL ADDITIONAL INFORMATION RECEIVED IN A SUBSEQUENT PUBLICATION PROVIDED PATIENT IDENTIFYING INFORMATION. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT P ROVIDED IN THE PUBLISHED LITERATURE. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD.

D

Patient 1

BEWERNICK, BH., KAYSER, S., GIPPERT, SM., SWITALA, C., COENEN, VA., SCHLAEPFER, TE. DEEP BRAIN STIMULATION TO THE MEDIAL FOREBRAIN BUNDLE FOR DEPRESSION-LONG-TERM OUTCOMES AND A NOVEL DATA ANALYSIS STRATEGY. BRAIN STIMUL. 2017;2017 FEB 9. DOI: 10.1016/J.BRS.2017.01.581. SUMMARY: BACKGROUND: DEEP BRAIN STIMULATION (DBS) OF THE SUPERO-LATERAL BRANCH OF THE MEDIAL FOREBRAIN BUNDLE (SLMFB) IN TREATMENT-RESISTANT DEPRESSION (TRD) IS ASSOCIATED WITH ACUTE ANTIDEPRESSANT EFFECTS. OBJECTIVE: LONG-TERM CLINICAL EFFECTS INCLUDING CHANGES IN QUALITY OF LIFE, SIDE EFFECTS AND COGNITION AS WELL AS LONG-TERM DATA COVERING FOUR YEARS ARE ASSESSED. METHODS: EIGHT TRD PATIENTS WERE TREATED WITH DBS BILATERAL TO THE SLMFB. PRIMARY OUTCOME MEASURE WAS A 50% REDUCTION IN MONTGOMERY-?SBERG DEPRESSION RATING SCALE (MADRS) (RESPONSE) AND REMISSION (MADRS

N

Patient 1

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.