CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96

EVENT REPORT DETAIL LISTING Page: 16
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA

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PRP Report No: MW1000594 Date Received: 02-FEB-94
Reporting Facility Type: VOLUNTARY
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PATIENT INFORMATION

Age: 48 YR. DOB: 30-NOV-45 Sex: M weight: 70kgs/154Lbs

ADVERSE EVENT OR PRODUCT PROBLEM

Adverse Event: Y Product Problem: N
Outcomes attributed to event: NOT APPLICABLE, BRAIN DAMAGE FROM CONVULSION

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

Event Description:

IN 1984, RPTR RECEIVED A TOTAL OF 21 ELECTRO CONVULSIVE THERAPY TREATMENTS. HE WAS NOT INFORMED THAT CONVULSIONS CAUSE BRAIN DAMAGE. THE RESULTING
MEMORY LOSS FROM BRAIN DAMAGE WAS MORE DISABLING FOR HIM THAN THE ORIGINAL PROBLEM. IN RPTR'S MIND ECT IS TOTALLY POLITICAL AND HAS NOTHING TO DO WITH TREATMENT; IT'S A FORM OF SOCIAL CONTROL AND NOTHING MORE.

DEVICE IDENTIFICATION

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

Manufacturer: UNKNOWN
Short name:UNKNOWN
Address:
UNKNOWN,

model:
Catalog:

Device Operator: HEALTH PROFESSIONAL
Expiration Date:
Device available For Evaluation