CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96

EVENT REPORT DETAIL LISTING Page: 28
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA

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PRP Report No: MwlOO38O8 Date Received: 25-OCT-94
Reporting Facility Type: VOLUNTARY
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PATIENT INFORMATION

Age: 32 YR. DOB: 28-FEB-57 Sex: F weight: 48kgs /1O6Lbs

ADVERSE EVENT OR PRODUCT PROBLEM

Adverse Event: Y product problem: Y
Outcomes attributed to event: HOSPITALIZATION, DISABILITY

Event Date: 01-JAN-90 Date of Report: 15-OCT-94

Event Description:

RPTR'S DR HAD HER UNDERGO 60 ECT TREATMENTS. SHE HAS SUBSEQUENTLY SUFFERED SEVERE MEMORY LOSS AND THE INABILITY TO CONCENTRATE AND ABSORB INFORMATION.
HAD SHE KNOWN OF THESE CONSEQUENCES, SHE WOULD NOT HAVE CONSENTED TO THE SHOCK TREATMENTS SHE FINDS THIS REPREHENSIBLE. PTS MUST BE INFORMED OF ALL
POSSIBLE RESULTS OF ECT. THE DR RECOMMENDED ADDITIONAL ECT 10/93. THIS DESPITE THE FACT THAT THE 60 ECT TREATMENTS DID NOT ALLEVIATE HER DEPRESSION. THIS IS A DANGEROUS AND INVASIVE PROCEDURE AND PTS MUST BE INFORMED OF THE POTENTIAL FOR PERMANENT DAMAGE.

DEVICE IDENTIFICATION

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

manufacturer: UNKNOWN
Short name:UNKNOWN
Address:


MODEL: UNKNOWN
Catalog,:

Device Operator: HEALTH PROFESSIONAL