CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96
EVENT REPORT DETAIL LISTING Page: 29
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA
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PRP Report No: Mw1D04624 Date Received: 30-DEC-94
Reporting Facility Type: VOLUNTARY
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PATIENT INFORMATION
Age: 21 YR. DOB:18-JAN-37 Sex: M Weight: 80kgs/1761bs
ADVERSE EVENT OR PRODUCT PROBLEM
Adverse Event: Y Product Problem: N
Outcomes attributed to event: LIFE THREATENING, HOSPITALIZATION, DISABILITY
Event Date: 01-DEC-58 Date of Report: 19-DEC-94
Event Description:
PT RECEIVED ONE ELECTROSHOCK TREATMENT IN 12/58 AND TEN ELECTROSHOCK TREATMENTS IN 1962,
ALL AGAINST HIS WILL, WITHOUT BEING ASKED & ON THE FIRST ECT WASN'T EVEN TOLD HE WAS
GOING TO GET AN ECT. PT DEVELOPED MASSIVE MEMORY LOSS IN 1962 AND COULDN'T REMEMBER WHAT
HIS MOTHER LOOKED LIKE AND FORGOT 99% OF HIS HIGHER MATH, 50% OF MUSIC THEORY AND 50% OF
TYPING
ABILITY. HE DEVELOPED EPILEPSY LATER, INSANITY, ILLUSIONS, DELUSIONS, VOICES, DEPRESSION,
SUICIDAL-MOODS, FEAR AND NIGHTMARES.
Relevant Test/Laboratory Data:
HAD MANY EEG's AND DIAGNOSTIC EXAMS.
Other related History:
BEFORE THE FIRST ECT AND BEFORE THE 1962 TREATMENTS PT WAS IN PERFECT
MENTAL AND PHYSICAL HEALTH, A BOXER, WEIGHT LIFTER, ATHLETE AND JUST
FINISHED COLLEGE. NEVER ARRESTED UNTIL 1959 FOR ANYTHING.
DEVICE IDENTIFICATION
Braid:ELECTROCONVULSIVE THERAPY DEVICE
Generic:
Product Code: GXC(NE) - DEVICE, ELECTROCONVULSIVE THERAPY
Manufacture: UNKNOWN
Short name:UNKNOWN
Address:
