FDA Adverse Event Injury Summary report: N

DEEP BRAIN STIMULATION LEAD

MDR report key: 1057813 · Received June 6, 2008

Report

Report Number
2182207-2008-03035
Event Type
Injury
Date Received
June 6, 2008
Report Date
May 8, 2008
Manufacturer
MEDTRONIC NEUROMODULATION
Product Code
MHY
PMA / PMN Number
P960009
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

JOURNAL REFERENCE: PLAHA P, KAHN S, GILL SS. BILATERAL STIMULATION OF THE CAUDAL ZONA INCERTA NUCLEUS FOR TREMOR CONTROL. J NEUROL NEUROSURG PSYCHIATRY 2008; 79(5): 504-513. THE VENTROLATERAL (VL) NUCLEUS OF THE THALAMUS IS THE COMMONLY CHOSEN TARGET FOR DEEP BRAIN STIMULATION (DBS) TO ALLEVIATE TREMOR. HOWEVER, IT HAS A POOR EFFICACY IN ALLEVIATING PROXIMAL TREMOR AND PATIENTS MAY DEVELOP TOLERANCE TO THE ACTION COMPONENT OF TREMOR. WE PERFORMED BILATERAL STIMULATION OF THE CAUDAL OR MOTOR PART OF THE ZONA INCERTA NUCLEUS (CZI) TO DETERMINE ITS SAFETY AND EFFICACY IN ALLEVIATING TREMOR. FIVE PTS WITH PARKINSONIAN TREMOR AND 13 WITH A RANGE OF TREMORS (HOLMES (HT), CEREBELLAR (CT), ESSENTIAL (ET), MULTIPLE SCLEROSIS (MS) AND DYSTONIC TREMOR (DT)) AFFECTING BOTH THE PROXIMAL AND DISTAL BODY PARTS UNDERWENT MRI GUIDED, BILATERAL CZI DBS. TREMOR WAS ASSESSED AT BASELINE AND AT A MEAN FOLLOW-UP OF 12 MONTHS. IN CONTRAST TO BILATERAL DBS OF THE VL NUCLEUS, IT IMPROVES ALL COMPONENTS OF TREMOR AFFECTING BOTH THE DISTAL AND PROXIMAL LIMBS AS WELL AS THE AXIAL MUSCULATURE. REPORTABLE EVENT: THERE WAS ONE SURGERY-RELATED COMPLICATION. THE SINGLE PT WITH HT DEVELOPED DYSPHAGIA FOR A PERIOD OF ABOUT 3 MONTHS POST-SURGERY. THIS WAS SECONDARY TO AN ERROR IN FRAME RELOCATION, WHICH RESULTED IN BOTH GUIDE TUBE STYLETTES BEING IMPLANTED INTO THE VIM NUCLEUS. BOTH THE STYLETTES WERE SUBSEQUENTLY RELOCATED TO THE CZI.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3389 UNK

Patients

Seq Age Sex Outcome Treatment
1 Other LEAD MODEL 3389 N=1| KINETRA MODEL 7428 N=1| EXTENSION MODEL UNK N=2| PROGRAMMER MODEL UNK N=1