BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIFY

    MDR report key: 1102323 · Received April 14, 2008

    Report

    Report Number
    6000153-2008-01978
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    GZB
    PMA / PMN Number
    k971756
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN WAS INDICATED ON THE UF REPORT; HOWEVER, THE DEVICE HAS NOT BEEN REC'D AT THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIFY * GZB MEDTRONIC VASCULAR 3998 V015626

    Patients

    Seq Age Sex Outcome Treatment
    1 * EXTENSION MODEL 37082 LOT#NKB006540N| EXPLANTED| IMPLANTED| IMPLANTED| EXPLANTED| IMPLANTABLE NEUROSTIMULATOR MODEL 37713| LOT# NJK702543H