CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96

EVENT REPORT DETAIL LISTING Page: 26
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA

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PRP Report No: MW10O3669 Date Received: 14-OCT-94
Reporting Facility Type: VOLUNTARY
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PATIENT INFORMATION

Age: 45 YR. DOB: 01-NOV-39 Sex: F weight: S5kgs /121 Lbs.

ADVERSE EVENT OR PRODUCT PROBLEM

Adverse Event: Y Product problem: Y
Outcomes attributed to event: HOSPITALIZATION, DISABILITY

Event Date: 01-JAN-85 Date of Report: 21 -SEP-94

Event Description:

RPTR HAD 10 ECT TREATMENTS AND WAS NEVER TOLD SHE COULD LOSE MEMORY AS SHE DID (SHORT-TERM AND LONG-TERM). SHE LOST ABOUT 15 YRS OF MEMORY. WHEN
RETURNED FROM HOSP RPTR COULD NOT IDENTIFY HER CLOTHES. SHE DID NOT KNOW HER CHILDREN'S AGES, LIKES, DISLIKES OR SCHOOL CLASSES. IT TOOK YEARS TO PIECE HER LIFE TOGETHER AND RPTR HAS DEALT AND STILL DEALS WITH MEMORY PROBLEMS, COGNITIVE PROBLEMS, ESPECIALLY VISUAL AND AUDITORY PROCESSING. THESE PROBLEMS EXIST TODAY AND IT IS AND HAS BEEN DIFFICULT TO HAVE A JOB.
RPTR, AT THIS LATE DATE, IS GETTING SOME HELP WITH COGNITIVE RETRAINING. RPTR COMPLAINED Or MEMORY LOSS AFTER 4TH ECT; BUT THEY CONTINUED TO GIVE 6
MORE. AFTER ECT RPTR'S BRAIN FELT SO "EMPTY" SHE WAS FEARFUL. AT THIS TIME RPTR RECALLS SEVERAL DRS TRYING TO HYPNOTIZE HER TO GET HER MEMORY BACK.

Other related History:

DEPRESSION DUE TO STRESS WITH MARRIAGE AND SON WHO WAS ADOLESCENT AND
DELINQUENT FROM SCHOOL AND USING ALCOHOL.

DEVICE IDENTIFICATION

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

Manufacturer:UNKNOWN
Short narne:UNKNOWN
Address