CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96

EVENT REPORTING DETAIL LISTING PAGE: 33
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA

---------------------------------------------------------------------------
PRP Report No: MW1007463 Date Received: 27-OCT-95
Reporting Facility Type: VOLUNTARY
---------------------------------------------------------------------------

PATIENT INFORMATION

Age: 44 YR. DOS: 21-SEP-44 Sex: F Weight: 56kgs/123lbs

ADVERSE EVENT OR PRODUCT PROBLEM

Adverse Event: Y Product Problem: N
Outcomes attributed to event: DISABILITY

Event Date: 01-JAN-89 Date of Report: 02-JUN-95

Event Description:

RPTR HAD MAJOR DEPRESSION DIAGNOSED FALL OF 1987. TREATED WITH VARIOUS MEDICATIONS UNTIL 1/89. THEN HAD SERIES OF 12 ECTS. IN MAY OF THAT YEAR, HAD ANOTHER SERIES OF 12. IN 1990 STARTED HAVING ECTS EVERY 2-3 WEEKS WITH A TOTAL OF ABOUT 50 TREATMENTS BY EARLY 1992. NOW SEVERE MEMORY LOSS OF TIME BACK TO ABOUT AGE 17. SHE WAS AN RN & HAD WORKED FOR 27 YRS IN A
HOSP. MEMORY LOSS INCLUDES HER PROFESSIONAL KNOWLEDGE LEAVING HER DISABLED.

Other Related History:

NC PRE-EXISTING PROBLEMS. NO ALCOHOL USE AT ALL.

DEVICE IDENTIFICATION

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

Manufacturer:UNKNOWN
Short name:UNKNOWN