CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96

EVENT REPORT DETAIL LISTING Page: 19
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA

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PRP Report No: MW1000676 Date Received: 08-FEB-94
Reporting Facility Type: VOLUNTARY
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PATIENT INFORMATION

Age: 46 YR. DOB: 18-MAY-47 Sex: F weight: kgs/ lbs

ADVERSE EVENT OR PRODUCT PROBLEM

Adverse Event: N product Problem: *
Outcomes attributed to event: LIFE THREATENING, HOSPITALIZATION, NOT APPLICABLE

Event Date: Date of Report: 24-JAN-94

Event Description:

RPTR WAS MISDIAGNOSED AS SCHIZOPHRENIC IN ORDER TO JUSTIFY THE ADMINISTRATION OF 15 ELECTROCONVULSIVE "TREATMENTS" TO HER AGAINST HER WILL AT AGE 17. EVERYONE EXCEPT FOR TWO 1O-YR-OLD BOYS ON THE PSYCHIATRIC UNIT OF THE HOSP WAS SUBJECTED TO SHOCK "TREATMENTS." FOLLOWING THE SERIES OF TREATMENTS RPTR HAD NO MENSTRUAL PERIOD FOR 9 MOS AND HER EYESIGHT WORSENED TO 20/200. RPTR HAD SEVERE MEMORY LOSS AND LEARNING DISABILITIES THAT HAVE REMAINED THROUGHOUT HER LIFE.

Relevant Test/Laboratory Data:

IN 1990 RPTR HAD NEUROPSYCHOLOGICAL TESTING DONE THAT CONFIRMS THE COGNITIVE DEFICITS RPTR HAS INCLUDING SEVERE MEMORY PROBLEMS AND OTHER LEARNING DISABILITIES FROM THE BRAIN DAMAGE FROM ECT.

Other Related History:

NA

DEVICE IDENTIFICATION

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

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