MAUDE MDR 8339159

MDR report key
8339159
Report number
3007566237-2019-00374
Event key
0
Event type
3
Date of event
2018-05-28
Date received
2019-02-14
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
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
1UNKNOWN IMPLANTABLE NEUROSTIMULATORMEDTRONIC NEUROMODULATIONMFRNEU_INS_STIMULATORNEU_INS_STIMULATORUNKNOWN* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-1401. H; 2. R

Event Narratives#

N

Patient 1

DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN. O?ATE-CADENA, N., CISNEROS-OTERO, M., RUIZ-CHOW, ?A., ARELLANO-REYNOSO, A., KOBAYASHI-ROMERO, LF., P?REZ-ESPARZA, R. DEEP-BRAIN STIMULATION IN TREATMENT-RESISTANT OBSESSIVE-COMPULSIVE DISORDER: CLINICAL AND MOLECULAR NEUROIMAGING CORRELATION. REVISTA COLOMBIANA DE PSIQUIATR?A. 2018. DOI: 10.1016/J.RCP.2018.05.002. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

SUMMARY: INTRODUCTION: OBSESSIVE-COMPULSIVE DISORDER IS DEFINED BY THE PRESENCE OF OBSESSIONS AND COMPULSIONS THAT CAUSE MARKED ANXIETY OR DISTRESS AND HAS BEEN ASSOCIATED WITH A DISRUPTION IN CORTICO-STRIATOTHALAMO-CORTICAL CIRCUITRY. AFTER TREATMENT, AROUND 50% OF PATIENTS CONTINUE TO EXPERIENCE INCAPACITATING SYMPTOMS. DEEP-BRAIN STIMULATION HAS BEEN SHOWN TO BE AN EFFECTIVE THERAPEUTIC ALTERNATIVE TO REGULAR TREATMENT. METHODS: CASE REPORT. CASE PRESENTATION: A (B)(6) WOMAN WITH A DIAGNOSIS OF TREATMENT-RESISTANT OBSESSIVE-COMPULSIVE DISORDER WAS TREATED WITH DEEP-BRAIN STIMULATION OF THE ANTERIOR LIMB OF THE INTERNAL CAPSULE. MOLECULAR IMAGING BEFORE AND AFTER THE PROCEDURE WAS OBTAINED AND CORRELATED WITH CLINICAL FEATURES. CONCLUSIONS: DEEP-BRAIN STIMULATION MAY BE A THERAPEUTIC ALTERNATIVE TO REGULAR CARE IN TREATMENT-RESISTANT OBSESSIVE-COMPULSIVE DISORDER AND CAN BE CORRELATED TO FUNCTIONAL CHANGES IN SUSPECTED ANATOMICAL STRUCTURES. REPORTED EVENT: A (B)(6) WOMAN WHO RECEIVED BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE NUCLEUS ACCUMBENS (NA) FOR OBSESSIVE COMPULSIVE DISORDER (OCD) ONE MONTH POST-IMPLANT EXPERIENCED NO RESPONSE TO OCD SYMPTOMS AND INSTEAD, HAD DEVELOPED DISTRESSING ANXIETY AND DEPRESSIVE SYMPTOMS THAT ELICITED VIOLENT BEHAVIOR TOWARDS HER FAMILY MEMBERS. DBS PARAMETERS WERE ADJUSTED MONTHLY WITH LITTLE RESPONSE AND PRESENTING WITH A HYPER-PRODUCTIVE SPEECH. DUE TO NON-RESPONSE AND NEW-ONSET ANXIOUS AND DEPRESSIVE SYMPTOMS, SHE WAS ADMITTED TO THE NEUROPSYCHIATRY DEPARTMENT FOR FURTHER EVALUATION. AFTER NEW DELIBERATION BY THE PSYCHOSURGERY COMMITTEE, THE DBS SITE WAS CHANGED TO THE ANTERIOR LIMB OF THE INTERNAL CAPSULE, BILATERALLY, AND PARAMETERS WERE MODIFIED. DURING THE FIRST WEEK, THIS CHANGE WAS FOLLOWED BY A NORMALIZATION OF HER SPEECH, DISAPPEARANCE OF DEPRESSIVE SYMPTOMS, AND IMPROVEMENT IN ANXIETY. AFTER A MONTH, RESPONSE WAS OBSERVED IN OCD SYMPTOMATOLOGY, WITH A YBOCS SCORE OF 30 (25% CHANGE). SHE NO LONGER PRESENTED VIOLENT BEHAVIOR NOR DEPRESSION, AND HER OBSESSIONS AND COMPULSIONS DIMINISHED DRASTICALLY, BEING ABLE TO PERFORM SOME OF HER DAILY CHORES. A NEW 18 FDG-PET WAS OBTAINED, SHOWING A NORMALIZATION OF THE METABOLISM IN THE ANATOMICAL SITES THAT SHOWED DISRUPTION AT BASELINE. THE PATIENT WAS REPORTEDLY IMPLANTED WITH A 3389 MODEL LEAD; HOWEVER, IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.