MAUDE MDR 349063

MDR report key
349063
Report number
2182207-2001-00279
Event key
0
Event type
3
Date received
2001-08-22
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
VICKI SCHREIBER
Address
800 53RD AVE. NE MINNEAPOLIS MN 55421 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DBSLEADMEDTRONIC INC.GYZ3380NAUNKYRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-08-2201. H

Event Narratives#

D

Patient 1

LITERATURE REPORT OF A PATIENT WITH A PAST HISTORY OF MI, SUFFERED FROM RIGHT THALAMIC BLEEDING, AND DEVELOPED LEFT SEVERE ACTION TREMOR. THE PATIENT HAD A NEUROSTIMULATION SYSTEM FOR TREMOR IMPLANTED IN 1992. THE PATIENT RECEIVED TREMOR RELIEF WITH STIMULATION. IN 1995, THE PATIENT UNDERWENT EMERGENCY CARDIOVERSION AT 100 J. AND 200 J. FOR PAROXYSMAL ATRIAL FIBRILLATION. ONE PADDLE WAS PLACED CLOSE TO THE RF RECEIVER IMPLANTED SUBCUTANEOUSLY AT THE ANTERIOR CHEST WALL. AFTER SUCCESSFUL CARDIOVERSION, THE ACTION TREMOR DISAPPEARED COMPLETELY. A CT SCAN OBTAINED LATER, SHOWED THE 3380 LEAD ARTIFACT AND COULD NOT DEMONSTRATE ANY CLEARLY DESTROYED STRUCTURES INCLUDING LESION OR THALAMIC BLEEDING. THE THALAMOTOMY EFFECT HAS LASTED FOR 4 YEARS. THE AUTHORS CONCLUDE THAT THE MOMENT CHANGES IN THE HIGH-VOLTAGE ELECTRICAL CURRENT OF THE CHEST WALL EVOKED CHANGES IN THE ELECTROMAGNETIC FIELDS, AND RADIOFREQUENCY EVOKED ELECTRICAL FLOW OCCURRED IN THE RADIOFREQUENCY RECEIVER CONNECTED TO THE STIMULATING ELECTRODE."