CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96
EVENT REPORT DETAIL LISTING Page: 22
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA
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PRP Report No: MWlOOlD3D Date Received: 10-MAR-94
Reporting Facility Type: VOLUNTARY
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PATIENT INFORMATION
Age: 73 YR. DOB: 03-NOV-20 Sex: M weight: 85kgs/l87Lbs
ADVERSE EVENT OR PRODUCT PROBLEM
Adverse Event: N Product Problem: *
Outcomes attributed to event: LOSS OF MEMORY
Event Date: Date of Report: 01-FEB-94
Event Description:
RPTR WAS NAUSEATED WHEN HE FIRST GOT OUT OF THE HOSPITAL. HE COULD NOT HOLD HIS PREVIOUS
POSITION. HE HAD PERMANENT MEMORY LOSS. IT IS DIFFICULT FOR HIM TO LEARN NEW THINGS. HIS
TEETH WERE DAMAGED BY SHOCK THERAPY.
Relevant Test/Laboratory Data:
CAT SCAN IN 1993 DID NOT REPORT BRAIN DAMAGE. "THIS IS NOT TRUE."
Other Related History:
TAKING THORAZINE FOR SCHIZOPHRENIA.
DEVICE IDENTIFICATION
Brand:ELECTRO SHOCK MACHINE
Generic:
Product Code: GXC(NE) - DEVICE, ELECTROCONVULSIVE THERAPY
Manufacturer: MEDCRAFT CORP.
Short name:MEDCRAFT
Address:
DARIEN, CT 06820
Model:UNKNOWN
Catalog:UNKNOWN
