MAUDE MDR 1550743

MDR report key
1550743
Report number
MW5013774
Event key
0
Event type
3
Date of event
2009-10-31
Date received
2009-11-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VARIAN 21EX WITH OBIPLATINUM LINEAR ACCELERATOR TRIOLOGY RADIOTHERAPYVARIANIYE21EX WITH OBI
2VARIANTRIOLOGY RADIOTHERAPYVARIANKPQ

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-11-3001. S

Event Narratives#

D

Patient 1

THE DATE OF THE EVENT ABOVE REFLECTS THE ONSET DATE. THE EVENT HAS NOT ENDED, BUT CONTINUES. A NEIGHBORHOOD ELECTRICAL CABLE UPGRADE WAS COMPLETED. PRECEDED BY TWO DISCONTINUOUS BUT SIMILAR EVENTS TWO DAYS LATER, A LOW FREQUENCY PULSE BEGAN, COMING FROM THE DIRECTION OF MEDICAL CENTER. I LIVE WITHIN A FEW HUNDRED FEET OF THE STREET ENTRANCE TO THE HOSPITAL IN A 3-STORY WOODEN HOME, ON A BEDROCK UPSLOPE THAT BEGINS ACROSS THE STREET. GRATES ALONG THE STREET SIDE OF THE HOSPITAL VENT HEAT BUILDUP FROM THE HOSPITAL'S 3 VARIAN LINEAR ACCELERATORS. THEIR ONCOLOGY SETUP ALSO INCLUDES A GE LIGHT-SPEED CT SIMULATOR, AND AN IMRT -INTENSITY MODULATED RADIATION THERAPY- UNIT FOR IMAGING. NOISE EMITS FROM THE GRATES CONTINUOUSLY AS DOES A WHINE FROM THE SPECIALIZED CIRCUIT BREAKER WHITE METAL BOX ABOVE THE GRATE ADJACENT TO THE HOSPITAL'S ENTRANCE. THERE IS ALSO AN INFRASOUND CANCER RESEARCH FACILITY IN A BUILDING LESS THAN A HUNDRED FEET FROM MY HOME, TOPPED WITH ROOFTOP CRYOGENICS UNITS WHICH CAUSED THE ENTIRE BUILDING TO WHINE AFTER THE POWER UPGRADE. THE LATTER ISSUE SEEMS TO HAVE BEEN ADDRESSED, AS THE NOISE STOPPED THE NIGHT AFTER I FORCED A HOSPITAL ENGINEER TO INVESTIGATE. THE HOSPITAL ASKED FOR THE POWER UPGRADE AND HAS BEEN CONTACTED ALONG WITH LOCAL OFFICIALS. IN FACT, I REMAIN IN WEEKLY CONTACT WITH THE HOSPITAL'S COMMUNITY LIAISON. THE HOSPITAL REFUSES TO ADMIT ANY CULPABILITY AND TYPICALLY REDIRECTS COMPLAINTS BY BLAMING OTHER PARTIES, LIKE THE DEPARTMENT OF PUBLIC WORKS -DEFECTIVE STREET LAMPS. I BELIEVE THE SOURCE OF THE POWERFUL PULSE IS RADIO FREQUENCY NOISE -RF---DUE TO IMPROPER SHIELDING, INSUFFICIENT CAPACITORS FOR HEAT SHIELDING, IMAGING DEVICE INTERFERENCE, OR TRANSITORY STRUCTURAL VIBRATION IN THE ILFM RANGES. I AM UNABLE TO SLEEP, AS THE PULSE IS STRONGEST AT NIGHT. IT IS AUDIBLE TO ME FOR 16 OUT OF 24 HOURS A DAY AND CAN'T BE BLOCKED BY EARPLUGS OR SIMILAR BARRIERS. THIS HAS BEEN OCCURRING FOR 31 NIGHTS STRAIGHT. WHITE NOISE, CYCLING AT 3 HZ, PLAYED THROUGH EARPHONES HAS HELPED ME SLEEP THE PAST THREE NIGHTS, UNCOMFORTABLY. HOWEVER, THE FATIGUE PERSISTS AND A HEADACHE AT THE BACK OF MY HEAD ABOVE MY SPINE BETWEEN MY EARS IS NOW EVER PRESENT. IT IS AS IF ANY BARRIER TO THE PULSE IS ONLY A TEMPORARY PANACEA. I ALSO EXPERIENCE EARACHES WITH OCCASIONAL POPPING. DATES OF USE: 2009.