CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96

EVENT REPORT DETAIL LISTING Page: 17
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA

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PRP Report No: Mw10O0663 Date Received:07-FEB-94
Reporting Facility Type: VOLUNTARY
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PATIENT INFORMATION

Age: 49 YR. DOB: 13-MAY-44 Sex: F weight: 55kgs/121 Lbs.

ADVERSE EVENT OR PRODUCT PROBLEM

Adverse Event: Y Product problem: Y
Outcomes attributed to event: NOT APPLICABLE

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

Event Description:

RPTR WITH COMPLAINT OF RETROGRADE MEMORY LOSS (ALMOST TOTAL FOR 6 MOS PRECEDING THE DATE SHOCK WAS COMMENCED), LOSS OF SOME SKILLS, SUCH AS TYPING AND CREATIVE WRITING AND PSYCHOLOGICAL DISTRESS SIMILAR TO WHAT HAS SINCE BEEN LABELED AS "POST-TRAUMATIC STRESS SYNDROME." RPTR HAS RECURRING NIGHTMARES 20 TO 30 YRS AFTER IT HAPPENED AND HAS BEEN UNABLE TO RECOVER EMOTIONALLY FROM THE HORROR OF THE EXPERIENCE RPTR CITES DR SPEAKING or THE ABC NEWS CLOSE-UP "MEDICINE & MADNESS" WHICH AIRED ON 5/26/77: "BUT QUITE ASIDE FROM THE HAZARD IN THE SENSE OF ACTUAL PHYSICAL HAZARD - I THINK THAT THE INDIVIDUAL CAN CERTAINLY EXPERIENCE IT AS SOMETHING THAT IS SORT OF FORCED UPON HIM OR DONE TO HIM. IT CAN BE FELT AS A KIND OF ATTACK..."

DEVICE IDENTIFICATION

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

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

model:UNKNOWN
Catalog: