CDRH MEDICAL DEVICE REPORTING SYSTEM

EVENT REPORT DETAIL LISTING Page: 7
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA

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PRP Report No: MwlOOOO9S Date Received: 10-DEC-93
Reporting Facility Type: VOLUNTARY
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PATIENT INFORMATION

Age: 46 YR. DOB: Sex: * Weight: 58kgs/128lbs

ADVERSE EVENT OR PRODUCT PROBLEM

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

Event Date: Date of Report: 02-DEC-93

Event Description:

COURSE OF SIX ECT TREATMENTS RESULTED IN SERIOUS MEMORY LOSS AND MAJOR INTERRUPTION OF USUAL ACTIVITIES.

Relevant Test/Laboratory Data:

NA

Other Related History:

POST TRAUMATIC STRESS DISORDER, MIGRAINES, SCIATICA

DEVICE IDENTIFICATION

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

Manufacturer:UNKNOWN
Short name:UNKNOWN
Address:
UNKNOWN

Model:
Catalog: