MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-08-24 for ALPHA-STIM 100 ALPA-STIM 100 A103136 manufactured by Electromedical Products International Inc..
[20194262]
Using alpha stim microcurrent for pain control in a pt with fibromyalgia and seizure disorder. The pt had a headache. The microcurrent was being tried to see if this pt would have a favorable response as several other fibromyalgia pts have experienced. Instead the ha got worse. The pt had increase in seizure activitiy and also depression - often occurring with the increased seizure activity in the past- their spouse reported this. Addition of a second antiseizure medication was necessary to return control as well as shift in anti depressant. Two other events occurred during this time per the pt. It was the anniversary of several important deaths for the pt. Secondly forest fires and smoke causing severe respiratory problems, that required hospitalization and testing for mi also occurred in the weeks of the increased seizures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029542 |
| MDR Report Key | 486965 |
| Date Received | 2003-08-24 |
| Date of Report | 2003-08-24 |
| Date of Event | 2003-08-01 |
| Date Added to Maude | 2003-10-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALPHA-STIM 100 |
| Generic Name | MICROCURRENT |
| Product Code | JXK |
| Date Received | 2003-08-24 |
| Model Number | ALPA-STIM 100 |
| Catalog Number | A103136 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 475853 |
| Manufacturer | ELECTROMEDICAL PRODUCTS INTERNATIONAL INC. |
| Manufacturer Address | 2201 GARRETT MORRIS PKWY MINERAL WELLS TX 760679484 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-08-24 |