CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96

EVENT REPORT DETAIL LISTING Page: 21
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA

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PRP Report No: Mw1O00933 Date Received: 0l-MAR-94
Reporting Facility Type: VOLUNTARY
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PATIENT INFORMATION

Age: 46 YR. DOB: 08-MAY-47 Sex: F weight: 45kgs/ 99Lbs

ADVERSE EVENT OR PRODUCT PROBLEM

Adverse Event: Y product Problem: N
Outcomes attributed to event: NOT APPLICABLE

Event Date: Date of Report: 31-JAN-94

Event Description:

IN EARLY 1967, RPTR WAS GIVEN 19 ELECTROSHOCK TREATMENTS, ADMINISTERED BILATERALLY EVERY OTHER DAY. AS A RESULT RPTR HAS NO MEMORIES OF CHILDHOOD
AND HAS BEEN PERMANENTLY DAMAGED, I.E., EVEN TODAY RPTR IS UNABLE TO LEARN AND RETAIN NEW INFO. EVENT DATE SHOWN AS EARLY 1967.

Other related History:

NONSMOKER, NON-DRINKER, NO ALLERGIES, CAUCASIAN FEMALE, NOT PREGNANT, GOOD
MEDICAL HEALTH, HISTORY OF SCHIZOPHRENIA.

DEVICE IDENTIFICATION

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

Manufacturer: MEDCRAFT CORP.
Short name:MEDCRAFT
Address:
DARIEN, CT O6820

Model: UNKNOWN
Catalog:UNKNOWN

Device Operator: OTHER
Expiration Date:
Device Available For Evaluation?: *