FDA.reportPublic FDA data

MAUDE MDR 8660267

MDR report key
8660267
Report number
3007566237-2019-01214
Event key
0
Event type
3
Date of event
2019-03-19
Date received
2019-05-31
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
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
1IMPLANTABLE NEUROSTIMULATORMEDTRONIC NEUROMODULATIONMBXNEU_INS_STIMULATORNEU_INS_STIMULATOR* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-3101. R

Event Narratives#

N

Patient 1

DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN; PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN. THE REPORTED EVENTS WERE FROM THE FOLLOWING LITERATURE ARTICLE: WANG Y, GREWAL SS, MIDDLEBROOKS EH, WORRELL GA, STEAD M, LUNDSTROM BN, BRITTON JW, WU M, VAN GOMPEL JJ. TARGETING ANALYSIS OF A NOVEL PARIETAL APPROACH FOR DEEP BRAIN STIMULATION OF THE ANTERIOR NUCLEUS OF THE THALAMUS FOR EPILEPSY. EPILEPSY RESEARCH 153 (2019) 1-6 DOI: 10.1016/J.EPLEPSYRES.2019.03.010. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

THE FOLLOWING REPORTED EVENTS WERE REPORTED IN LITERATURE ARTICLE: 1. PATIENT 1: ONE (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT BILATERAL ANTERIOR NUCLEUS OF THE THALAMUS (ANT) DEEP BRAIN STIMULATION (DBS) FOR TREATMENT OF EPILEPSY. NINE MONTHS AFTER IMPLANT, THE PATIENT EXPERIENCED A BATTERY SITE INFECTION. THIS RESULTED IN EXPLANT OF THE BATTERY AND LEAD EXTENSIONS. THE CAUSE OF THE DELAYED INFECTION WAS UNKNOWN, BUT THE PATIENT DID HAVE DENTAL WORK ONE MONTH PRIOR TO THE INFECTION. 2. PATIENT 4: ONE (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT BILATERAL ANT DBS FOR TREATMENT OF EPILEPSY. THE PATIENT EXPERIENCED A FRACTURE OF THE RIGHT-SIDE LEAD 18 MONTHS AFTER THE IMPLANT SURGERY. THE LEAD WAS SUBSEQUENTLY REPLACED. 3. PATIENT 9: ONE (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT BILATERAL ANT DBS FOR TREATMENT OF EPILEPSY. THE PATIENT EXPERIENCED TRANSIENT LEFT HEMIPARESIS. AFTER IMPLANT, THE PATIENT DEVELOPED TRANSIENT CONTRALATERAL MOTOR WEAKNESS LASTING ONE WEEK. THIS WAS ATTRIBUTED TO A CENTROMEDIAN INTRA-LAMINAR PARAFASCICULAR COMPLEX (CMPF) LEAD THAT WAS PLACED THROUGH THE MOTOR CORTEX RATHER THAN RELATED TO THE ANT LEAD.