CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96

EVENT REPORT DETAIL LISTING Page: 11
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA

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PRP Report No: MwlOOO5Ol Date Received: 26-JAN-94
Reporting Facility Type: VOLUNTARY
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PATIENT INFORMATION

Age: 61 YR. DOB: 20-MAY-32 Sex: F weight: 68kgs/150lbs

ADVERSE EVENT OR PRODUCT PROBLEM

Adverse Event: Y Product Problem: N
Outcomes attributed to event: MEMORY LOSS OVER YRS

Event Date: Date of Report: 18-JAN-94

Event Description:

RPTR IS DEPRESSIVE PSYCHOTIC. EPISODE CAUSED HOSPITALIZATION. TREATMENT AUTHORIZED BY DR. AT THE TIME OF ECT TREATMENT RPTR WAS A TRAINED AND
EXPERIENCED HIGH SCHOOL FOREIGN LANGUAGE TEACHER. THE MEMORY LOSS WAS WIDESPREAD AND LASTED FOR MANY YRS. RPTR HAS HAD TO READ TABLES OF CONTENTS
TO TEXTBOOKS FOR HER BASIC KNOWLEDGE TO COME BACK. IN 1977, SHE RETURNED TO TEACHING AND KNEW SHE WAS IN TROUBLE AS SHE MADE THE SAME MISTAKES SHE HAD
IN PRACTICE TEACHING. FOR AN EDUCATED PERSON THE EXPERIENCE OF ECT WAS DEVASTATING AND SHOULD NOT EVER BE USED UNLESS ORAL MEDICATION CANNOT BE USED. THERE WAS NO SPECIFIC CONSENT FORM FOR ECT.

Other related History:

3 MONTHS POSTPARTUM

DEVICE IDENTIFICATION

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

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