FDA Adverse Event Summary report: N

DEEP BRAIN STIMULATION DEVICES

MDR report key: 921670 · Received September 21, 2007

Report

Report Number
2182207-2007-03047
Date Received
September 21, 2007
Report Date
September 29, 2006
Manufacturer
MEDTRONIC NEUROMODULATION
Product Code
MHY
PMA / PMN Number
P960009
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

JOURNAL REFERENCE: JAGGI JURG L, BALTUCH GORDON H DEEP BRAIN STIMULATION INACTIVITY CAN PRODUCE UNEXPECTED HIGH ELECTRODE IMPEDANCES WHEN REACTIVATED, LEADING TO A FALSE CONCLUSION OF WIRE FRACTURE. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. 2005; 83 (5-6): 187-9. THE ARTICLE DISCUSSES A CASE REPORT ABOUT A WOMAN WITH A 10-YEAR HISTORY OF PARKINSONS WHO UNDERWENT BILATERAL STN DEEP BRAIN STIMULATION IMPLANTATION (KINETRA, MODEL 3389 LEADS AND UNK EXTENSIONS) IN 2004 FOR THE TREATMENT OF PERSISTENT TREMOR AND MOTOR FLUCTUATIONS. REPORTABLE EVENTS: IPG (N=1), EXTENSION LEAD (N=1): THE PT EXPERIENCED AN INFECTION TWO MONTHS AFTER THE IMPLANT. THE PT NOTICED A PATCH OF REDNESS AT THE STIMULATOR SITE CAUSING AN ITCHING AND BURNING SENSATION. SHE WAS TREATED WITH STEROIDS WITH SOME RESOLUTION OF THE SYMPTOMS INITIALLY. WHEN THE SYMPTOMS PERSISTED, SHE WAS SCHEDULED FOR REMOVAL OF THE AFFECTED IMPLANT A FEW DAYS LATER. DURING SURGERY, THE STIMULATOR WAS FOUND TO BE COVERED WITH PUS AND WAS REMOVED. THE WOUND WAS THEN WASHED WITH ANTIBIOTIC SOLUTION. THE EXTENSION WIRES WERE CUT AS FAR DISTALLY FROM THE STIMULATOR AS POSSIBLE. AGAIN THE AREA WAS FLUSHED WITH ANTIBIOTIC SOLUTION AND A PENROSE DRAIN WAS PLACED THROUGH THE INCISION. THE PT WAS PUT ON AN IV ANTIBIOTIC (VANCOMYCIN, 100 MG Q.D.) FOR 6 WEEKS. AFTER SUCCESSFUL ANTIBIOTIC TREATMENT, A NEW STIMULATOR AND EXTENSION WIRE WERE REIMPLANTED 2 MONTHS LATER. LEAD (N=1) INTRAOPERATIVE TESTING OF THE REPLACEMENT DEVICE YIELDED UNUSUALLY HIGH ELECTRODE IMPEDANCES AND LOW CURRENTS ON ONE LEAD ACROSS ALL FOUR CONTACTS. VISUAL INSPECTION OF THE EXPOSED HARDWARE, HOWEVER, DID NOT REVEAL ANY DEFECTS. SUBSEQUENT IMPEDANCE MEASUREMENTS YIELDED NORMAL VALUES AND AFTER THE PT AWOKE FROM ANESTHESIA, GOOD SYMPTOM CONTROL WAS AGAIN ACHIEVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DEEP BRAIN STIMULATION DEVICES MHY MEDTRONIC NEUROMODULATION NA

Patients

Seq Age Sex Outcome Treatment
1 65 YR Hospitalization| R