FDA Adverse Event Malfunction Summary report: N

NEUROSTIMULATOR IMPLANT

MDR report key: 13506732 · Received February 9, 2022

Report

Report Number
MW5107375
Event Type
Malfunction
Date Received
February 9, 2022
Date of Event
September 27, 2021
Report Date
February 2, 2022
Manufacturer
UNK
Product Code
LGW
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MD, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

MY DENTIST AND I ARE ALARMED AT SOME OF THE READINGS FROM A GQ ELECTRONICS GQ EMF METER EMF-380V2 FROM THE (B)(6) WEBSITE, WHICH ARE CONSIDERED HIGH, BASED ON (A) THE INFORMATION CARD ACCOMPANYING THE METER, (B) THE METER'S QUICK, LOUD BEEPING AND (C) THE METER'S INDICTOR LIGHT BLINKING RED. IT WAS BECAUSE OF MY DENTIST'S CONCERNS OF MY TOOTH'S RAPID DETERIORATION VIA RESORPTION AND HIS SUGGESTIONS THAT I GET THE METER, THAT I DECIDED TO TAKE THESE READINGS. A. MEASUREMENT DATE: ON OR ABOUT (B)(6) 2021 METER READINGS FROM MODEM: READINGS: EACH NUMBER WAS SUBJECTIVELY APPROXIMATED TO BE THE MIDDLE OF THE VALUES OF THE STREAM OF READOUT NUMBERS, 0VER 10-15 SECS. THE DETERMINED NUMBER (E.G., EF) OR NUMBERS (E.G., EF, RF, EMF) WERE TRANSCRIBED INTO A NOTEBOOK OR PAD. FRONT MIDDLE DISTANCE EF, RF, EMF ZERO INCHES 60 385 290 2 INCHES(APPROX.) 9-15 49 192 2.5 INCHES(APPROX.) 3 298 21 5 INCHES (APPROX.) 1 140-340 6.1 8 INCHES (APPROX.) 1 140-200 0.7 15 INCHES 1 22.57 0.7 METER READINGS FROM MODEM: READINGS: EACH NUMBER WAS SUBJECTIVELY APPROXIMATED TO BE THE MIDDLE OF THE VALUES OF THE STREAM OF READOUT NUMBERS, 0VER 10-15 SECS. THE DETERMINED NUMBER (E.G., EF) OR NUMBERS (E.G., EF, RF, EMF) WERE TRANSCRIBED INTO A NOTEBOOK OR PAD. BACK MIDDLE DISTANCE EF, RF, EMF ZERO INCHES 160 850 14 2 INCHES(APPROX.) 127 890 11 2.5 INCHES(APPROX.) 63 980 21 3 INCHES(APPROX.) 61 1039 14 5 INCHES (APPROX.) 66 1000 13.6 8 INCHES (APPROX.) 51 800 2.1 15 INCHES 25 500 1.2 B. MEASUREMENT DATE: ON (B)(6) 2021 EACH NUMBER WAS SUBJECTIVELY APPROXIMATED TO BE THE MIDDLE OF THE VALUES OF THE STREAM OF READOUT NUMBERS, 0VER 10-15 SECS. THE DETERMINED NUMBER (E.G., EF) OR NUMBERS (E.G., EF, RF, EMF) WERE TRANSCRIBED INTO A NOTEBOOK OR PAD. ZERO DISTANCE EF, RF, EMF IN FRONT 70 540 272 IN BACK 60 1039 15.7 ON TOP 59 1050 10.3 BELOW YOU WILL FIND THE METER READINGS FROM TWO DAYS LATER, ON (B)(6) 2021, BEFORE THE (B)(6) TECHNICIANS CAME. THE EMF READINGS FOR THE FRONT OF THE MODEM ARE EXTREMELY HIGH, WITH THE 335.7 READING ABOVE THE THRESHOLD CORRESPONDING WITH "AVOID STAY IN THE AREA" (100MG), ACCORDING TO THE GUIDANCE CARD. THE RF READING ON TOP OF THE MODEM, LIKEWISE, COINCIDES WITH "AVOID STAY IN THE AREA" (1000MG), ACCORDING TO THE GUIDANCE CARD. THE EF READING FALLS BETWEEN THE THRESHOLDS OF "CHECK REGULARLY" (30V/M) AND "NOT RECOMMENDED FOR LONG TIME STAY" (100 V/M) FOR ALL POSITIONS SURROUNDING THE MODEM. B. MEASUREMENT DATE: ON (B)(6) 2021 EACH NUMBER WAS SUBJECTIVELY APPROXIMATED TO BE THE MIDDLE OF THE VALUES OF THE STREAM OF READOUT NUMBERS, 0VER 10-15 SECS. THE DETERMINED NUMBER (E.G., EF) OR NUMBERS (E.G., EF, RF, EMF) WERE TRANSCRIBED INTO A NOTEBOOK OR PAD. ZERO DISTANCE EF, RF, EMF IN FRONT 70 125 335.7 IN BACK 62 600 22.7 ON TOP 50 1000 7.1 I'VE SYSTEMATICALLY TESTED THE MODEM BY PLACING THE METER , TOP, BACK FRONT AND MEASURED THE READINGS FROM TOUCHING THE MODEM TO 15 INCHES AWAY (FOR FRONT AND BACK OF MODEM). IN BRIEF, EMF IS EXTREMELY HIGH TOUCHING MODEM IN FRONT (BLINKING RED WITH EMF'S 270-350); IN THE BACK OF THE MODEM RF IS EXTREMELY HIGH (1,000). THE READINGS DECREASE STARTING 3 INCHES FROM THE MODEM AT THE FRONT. THE RF REMAINS HIGH. IV. (B)(6) VISIT TO CHECK MY MODEM'S HIGH EMF AND RF METER READINGS ON (B)(6) 2021 (B)(6) CAME TO MY HOME AND CONFIRMED THAT THE METER READINGS WERE HIGH WHEN THE METER WAS PLACED IN FRONT OF THE MODEM. TWO TECHNICIANS CAME. THEY REPLACED THE MODEM WITH ANOTHER MODEM. THAT SECOND MODEM HAD A HIGH READING (325) MUCH HIGHER ABOVE THE THRESHOLD CORRESPONDING WITH "AVOID STAY IN THE AREA" (100MG), ACCORDING TO THE GUIDANCE CARD WHEN THE METER WAS PLACED IN FRONT OF THE MODEM. THE REPORT WILL CONTINUE BELOW. (B)(6). BELOW YOU WILL FIND THE METER READINGS FROM TWO DAYS LATER, ON (B)(6) 2021, BEFORE THE (B)(6) TECHNICIANS CAME. THE EMF READINGS FOR THE FRONT OF THE MODEM ARE EXTREMELY HIGH, WITH THE 335.7 READING ABOVE THE THRESHOLD CORRESPONDING WITH "AVOID STAY IN THE AREA" (100MG), ACCORDING TO THE GUIDANCE CARD. THE RF READING ON TOP OF THE MODEM, LIKEWISE, COINCIDES WITH "AVOID STAY IN THE AREA" (1000MG), ACCORDING TO THE GUIDANCE CARD. THE EF READING FALLS BETWEEN THE THRESHOLDS OF "CHECK REGULARLY" (30V/M) AND "NOT RECOMMENDED FOR LONG TIME STAY" (100 V/M) FOR ALL POSITIONS SURROUNDING THE MODEM. B. MEASUREMENT DATE: ON (B)(6) 2021 EACH NUMBER WAS SUBJECTIVELY APPROXIMATED TO BE THE MIDDLE OF THE VALUES OF THE STREAM OF READOUT NUMBERS, 0VER 10-15 SECS. THE DETERMINED AGAIN, BOTH MY DENTIST AND I ARE ALARMED AT SOME OF THE READINGS, WHICH ARE CONSIDERED HIGH, BASED ON (A) THE INFORMATION CARD ACCOMPANYING THE METER, (B) THE METER'S QUICK, LOUD BEEPING AND (C) THE METER'S INDICATOR LIGHT BLINKING RED. IT WAS BECAUSE OF MY DENTIST'S CONCERNS OF MY TOOTH'S RAPID DETERIORATION VIA RESORPTION AND HIS SUGGESTIONS THAT I GET THE METER, THAT I DECIDED TO TAKE THESE READINGS. I AM ASKING THE FDA TO CONSIDER THE SAFETY OF MODEMS/ROUTERS WITHIN THE HOME, BOTH IN TERMS OF THE SAFETY OF THE DEVICES AND IN THE RECOMMENDED DISTANCES FOR THE DEVICES TO BE CONSIDERED SAFE. BASED ON THE DESCRIBED TESTING BY THE (B)(6) TECHNICIANS, IT APPEARS THAT THESE HIGH ROUTER READINGS ARE FOUND WITHIN THE HOME. THESE HIGH ROUTER/MODEM READINGS (ESPECIALLY FOR EMF'S) ARE FOUND WHEN THE METER IS WITHIN A FEW INCHES OF THE METER AND ARE EXTREMELY HIGH WHEN THE METER IS TOUCHING THE FRONT OF THE MODEM. THIS IS FOUND FOR BOTH THE (B)(6) MODEMS (ORIGINAL AND REPLACEMENT). I SHOULD ADD THAT NO TECHNICIAN EVER MENTIONED THAT ROUTERS WOULD HAVE SUCH HIGH READINGS, NOR HAVE THEY EVER STATED ANY CONCERN REGARDING THE CLOSENESS OF THE ROUTER. I USE A NEUROSTIMULATOR IMPLANT, MY CONCERN IS WITH WIFI FROM MODEM. FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
80623 NEUROSTIMULATOR IMPLANT STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW UNK

Patients

Seq Age Sex Outcome Treatment
1 68 YR Male Other B COMPLEX| B6| CARBAMAZEPINE| FIBERCON | LAMOTRIGINE| LYRICA| MIRALAX | NEUROSTIMULATOR| STATIN