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CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96
EVENT REPORT DETAIL LISTING Rage: 13
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA
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PRP Report No: MW000559 Date Received: 02-FEB-94
Reporting Facility Type: VOLUNTARY
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PATIENT INFORMATION
Age: 56 YR. DOB: Sex: F weight: 66kgs/145Lbs
ADVERSE EVENT OR PRODUCT PROBLEM
Adverse Event: Y Product Problem: N
Outcomes attributable to Event: MEMORY LOSS
Event Date: Date of Report: 15-JAN-94
Event Description:
ONGOING MEMORY LOSS FOR EVENTS CIRCA 1983-1987 AFTER SERIES OF SHOCK TREATMENTS
ADMINISTERED DURING MAJOR DEPRESSION LASTING FROM 1984-1986. CONTINUED DIFFICULTY
MEMORIZING NEW MATERIAL. MEMORY DIFFICULTIES RESULT IN LOSS OF CONFIDENCE IN SELF/ANXIETY.
Other Related History:
DEPRESSION CONTINUED AFTER TREATMENTS.
DEVICE IDENTIFICATION
Brand:ELECTROSHOCK DEVICE
Generic:
Product Code: CXC (NE) - DEVICE, ELECTROCONVULSIVE THERAPY
Manufacturer: UNKNOWN
Short name:UNKNOWN
Address:
UNKNOWN,
Model:
Catalog:
Device Operator: HEALTH PROFESSIONAL
Expiration Date:
Device Available For evaluation: *
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