CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96

EVENT REPORT DETAIL LISTING Page: 24
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA

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PRP Report No: Mw1003488 Date Received: 23-SEP-94
Reporting Facility Type: VOLUNTARY
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PATIENT INFORMATION

Age: * DOB: 20-MAY-49 Sex: F weight: 57kgs /l25lbs

ADVERSE EVENT OR PRODUCT PROBLEM

Adverse Event: Y product Problem: N
Outcomes attributed to event: BRAIN-MEMORY DAMAGE

Event Date: Date of Report:

Event Description:

BETWEEN JANUARY AND MARCH OF 1967 RPTR WAS ADMINISTERED 15 ELECTROCONVULSIVE SHOCK TREATMENTS (ECT). AFTER 27 YRS, SHE CONTINUES TO SUFFER MEMORY LOSS. SHE HAS NEAR-TOTAL AMNESIA FOR THE 2 YRS PRECEDING ECT. HER SHORT TERM MEMORY AND SENSE OF DIRECTION ALSO CONTINUE TO BE MUCH WEAKENED SINCE THE ECT. SHE IS AN "ACADEMIC;" THESE MEMORY PROBLEMS DO NOT TEND TO SHOW UP ON STANDARDIZED TESTS; THEY TEND TO BE MORE EXPERIENTIAL, MORE PERSONAL.

DEVICE IDENTIFICATION

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

Manufacturer: UNKNOWN
Short name:UNKNOWN
Address:


Model:
Catalog:

Device Operator: INVALID DATA