FDA.reportPublic FDA data

MAUDE MDR 486996

MDR report key
486996
Report number
MW1029543
Event key
0
Event type
3
Date of event
2003-08-23
Date received
2003-08-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALPHA STIMMICROCURRENTELECTROMEDICAL PRODUCTS INT. INC.JXKALPHA - STIM 100**NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-08-2401. O

Event Narratives#

D

Patient 1

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.

D

Patient 1

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.