CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96

        EVENT REPORT DETAIL LISTING Page: 25
            FOI RELEASABLE FORMAT
    SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
        RECORDS MEETING QUERY CRITERIA

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PRP Report No: Mw1O03685 Date Received: 13-OCT-94
Reporting Facility Type: VOLUNTARY
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            PATIENT INFORMATION

Age: 18 YR. DOB: 12-FEB-57 Sex: M weight: 75kgs /165 Ibs

        ADVERSE EVENT OR PRODUCT PROBLEM

Adverse Event: Y Product Problem: N
Outcomes attributed to event: HOSPITALIZATION, DISABILITY

Event Date: 01-OCT-75 Date of Report: 30-SEP-94

Event Description:

RPTR COMPLAINED OF TROUBLE BREATHING, TROUBLE WITH BONES (DISLOCATED ARMS), TURNED VIOLENT AFTER SHOCK (NO HISTORY OF VIOLENCE), MEMORY PROBLEMS, SUDDEN ONSET OF DEPRESSION, HOSPITALIZED FOR 2 YEARS SUBSEQUENTLY, INTERMITTENTLY THEREAFTER STILL DISABLED.

Other Related History:

ABUSED CHILD, SOCIAL ISOLATION, OTHERWISE PHYSICALLY HEALTHY, NO HISTORY OF
DEPRESSION
            DEVICE IDENTIFICATION

Brand:ELECTROCONVULSIVE THERAPY DEVICE
Generic:ELECTROCONVULSIVE THERAPY DEVICE
Product Code: GxC(NE) - DEVICE, ELECTROCONVULSIVE THERAPY

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

model:
Catalog:

Device Operator: HEALTH PROFESSIONAL