ALPHA-STIM 100 ALPHA STIM 100 CLASS IIA *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-27 for ALPHA-STIM 100 ALPHA STIM 100 CLASS IIA * manufactured by Electromedical Products International, Inc..

Event Text Entries

[245057] Rptr was referred to dr in 2001 to help treat or diagnose a possible tmj dental problem. Rptr may have had after a root canal on tooth #31. Dr told rptr he thought rptr had tmj from recent dental work and suggested rptr use the alpha-stim 100 stimulator to relieve the muscle where rptr had dental work. Dr used it at currents ranging from 0. 5 hertz to 2. 0 hertz for one hr on each of these days. Rptr was not aware how the stimulator worked, or if any side effects were possible. Dr presented the machine to rptr as a non-medicated conservative approach to medications. Rptr was in no pain prior to the use of this machine other than mild headaches and tooth pain from a recent extraction of molar #31 and a wisdom tooth due to a failed root canal by another dentist. The alpha-stim 100 has disrupted rptr's nervous system and caused rptr several medical problems, ranging from irregular heart rate and abnormal ekg from three area hosps, also tingling sensations, nerves jumping, muscle and bone aches and pains, easy bruising, and ongoing diarrhea (lasting over a month), dehydration, anxiety, psychological imbalances. You name it and this machine affected rptr's entire body. Rptr was not taking any medication before or during the use of the alpha-stim 100. It has been one month and rptr has been in four hosps and has seen over seven drs, all of whom were dismayed that this machine was used on rptr. Rptr has been told that there is no known medical treatment for rptr's side effects because hosps and "legitimate" drs do not use such devices. Rptr contacted the mfr after this happened and dr told rptr that he had no answers because he had never had a report of rptr's type of side effects. He also said alpha-stim researchers had no antidote or treatment for what happened to rptr because the research simply has not been done. Dr does not want to accept liability for what this machine has done to rptr. Rptr has been in constant pain emotionally, physically and spiritually since this treatment. Rptr is a sunday school teacher and has been unable to teach class since this procedure. Rptr is also a single parent of three children who have worried about rptr to no end, and rptr's body aches constantly. For a normal healthy person such as rptr to have rptr's whole life change from the use of two treatments from the stimulator, rptr believes it should be taken off the market.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1022748
MDR Report Key349789
Date Received2001-08-27
Date of Report2001-08-07
Date of Event2001-07-22
Date Added to Maude2001-09-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameALPHA-STIM 100
Generic NameCRANIAL STIMULATOR
Product CodeJXK
Date Received2001-08-27
Model NumberALPHA STIM 100 CLASS IIA
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key339098
ManufacturerELECTROMEDICAL PRODUCTS INTERNATIONAL, INC.
Manufacturer Address2201 GARRETT MORRISS PKWY MINERAL WELLS TX 76067 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention 2001-08-27

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