BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PISCES QUAD

    MDR report key: 217825 · Received March 30, 1999

    Report

    Report Number
    2182207-1999-00084
    Event Type
    Malfunction
    Date Received
    March 30, 1999
    Date of Event
    January 14, 1999
    Report Date
    March 12, 1999
    Manufacturer
    MEDTRONIC INC.
    Product Code
    GZB
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PISCES QUAD Implant LEAD FOR CENTRAL NERVOUS SYSTEM STIMULATION GZB MEDTRONIC INC. 3487A L53098

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization 7425 ITREL 3 IMPLANTABLE PULSE GENERATOR IMPLANTED| 6/25/1998, STATUS UNK.