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 ALPHA - STIM 100 * manufactured by Electromedical Products Int. Inc..
[296350]
Add'l info rec'd from mfr 10/29/03: conclusion: this symptom has never been reported previously in the 22 years this technology has been on the market, or in any research study on these, or any other cranial electrotherapy stimulator. It is probable that this pt, who is evidently diagnosed as having an attention deficit disorder (add), had anxiety over the use of this device which caused them to experience the "odd sensation in chest" that was reported. The reporting physician did not consider the reported event significant enough to require any further diagnostic work-up or therapy. Further, the pt has not experienced any permanent impairment of any body function in the two months since this problem was reported. Accordingly, no further action is deemed necessary.
Patient Sequence No: 1, Text Type: D, B5
[302896]
During trial of cranial electro stimulatin for add pt, observed effect at low settings. After about 3-5 minutes an odd sensation in the chest was experienced. This stopped immediately when the stimulation was removed. No further use of the machine occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029543 |
| MDR Report Key | 486996 |
| Date Received | 2003-08-24 |
| Date of Report | 2003-08-24 |
| Date of Event | 2003-08-23 |
| 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 | 3 |
| 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 |
| Generic Name | MICROCURRENT |
| Product Code | JXK |
| Date Received | 2003-08-24 |
| Model Number | ALPHA - STIM 100 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 475884 |
| Manufacturer | ELECTROMEDICAL PRODUCTS INT. INC. |
| Manufacturer Address | 2201 GARRETT MORRIS PKWY MINERAL WELLS TX 760679484 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-08-24 |