DEVICE REPORTING SYSTEM

EVENT REPORT DETAIL LISTING Page: 31
FOI RELEASABLE FORMAT
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RECORDS MEETING QUERY CRITERIA

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PRP Report No: MW10O4929 Date Received: 31 -JAN-95
Reporting Facility Type: VOLUNTARY
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PATIENT INFORMATION

Age: DOB: Sex: * Weight: kgs/ lbs

ADVERSE EVENT OR PRODUCT PROBLEM

Adverse Event: Y product Problem: N
Outcomes attributed to event

Event Date: Date of Report: 13-JAN-95

Event Description:

SERIOUS ADVERSE EFFECTS FROM USE OF THE ELECTRIC SHOCK MACHINE. RPTR HAS WORKED FOR FIVE YEARS WITH PTS RECEIVING ELECTROSHOCK (E.C.T.). RPTR HAS OBSERVED PERSISTENT, PERMANENT MEMORY IMPAIRMENT IN MANY OF THESE PTS. SOMETIMES THIS MEMORY IMPAIRMENT HAS CAUSED HOSPITALIZATION TO BE EXTENDED OR IT HAS CAUSED DISABILITY. THE PTS WERE NOT GIVEN ACCURATE INFO ABOUT
POTENTIAL SIDE EFFECTS/RISKS AND THE DR'S DETERMINATION OF THE AMOUNT OF ELECTRICITY AND HOW TO GIVE IT WAS ARBITRARY. RPTR FEELS THIS MACHINE AND ITS ADVERSE EFFECTS NEEDS MUCH MORE FDA MONITORING.

DEVICE IDENTIFICATION

Brand:THYMATRON
Generic:ELECTROCONVULSIVE TREATMENT MACHINE
Product Code: GXC(NE) - DEVICE, ELECTROCONVULSIVE THERAPY

Manufacturer: MEDCRAFT CORP.
Short name:MEDCRAFT
Address:
DARIEN, CT 06820


Device Operator: HEALTH PROFESSIONAL
Expiration Date:
Device Available For Evaluation: *