CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96

EVENT REPORT DETAIL LISTING Page: 14
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA

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PRP Report No: MW1000563 Date Received: 02-FEB-94
Reporting Facility Type: VOLUNTARY
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PATIENT INFORMATION

Age: 66 YR. DOB: 24-MAY-27 Sex: F weight: 84kgs/185bs

ADVERSE EVENT OR PRODUCT PROBLEM

Adverse Event: N Product Problem:
Outcomes attributed to event: NOT APPLICABLE

Event Date: Date of Report: 19-JAN-94

Event Description:

RPTR HAS PERMANENT MEMORY LOSS. SHE RECEIVED SHOCK THERAPY AGAINST HER WILL. THE TEMPORARY MEMORY LOSS WAS TREMENDOUS. SHE FORGETS HOW TO COOK, HOW TO KNIT, EVEN READING WAS DIFFICULT; ALTHOUGH SHE  ALREADY HAD A BA DEGREE AT THE TIME. RPTR HAD TO RELEARN MANY SKILLS; WENT BACK TO COLLEGE, AND RECEIVED A MBA. CUT THERE IS A PART OF HER MEMORY THAT SHE CANNOT GET TO. IT IS LOST FOREVER. RPTR CONSIDERS THIS A RAPE AGAINST HER MIND; PARTICULARLY SINCE IT WAS ADMINISTERED AGAINST HER WILL.

Other related History:

NO PREEXISTING MEDICAL CONDITIONS. RPTR DOES NOT.SMOKE OR DRINK NOR DID SHE
AT THE TIME. CAUCASIAN.

DEVICE IDENTIFICATION

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

Manufacturer: MEDCRAFT
Short narne:MEDCRAFT
Address:
DARIEN, CT 06820

Model:
Catalog: