BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLOGICAL QUAD LEAD

    MDR report key: 1994287 · Received January 14, 2011

    Report

    Report Number
    3007566237-2011-00384
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THAT DURING THE SURGICAL PROCEDURE AFTER THE INCISION WAS CLOSED, THE LEAD WAS TESTED FOR STIMULATION. THE RESPONSE FROM POLES #0 AND 1 WAS NOT AS EXPECTED. IT WAS NOTED THAT THERE WAS BLOOD IN THE LEAD. THE INCISION WAS RE-OPENED AND ANOTHER LEAD WAS IMPLANTED. THERE WERE NO FURTHER PROBLEMS WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROLOGICAL QUAD LEAD INTERSTIM TINED LEAD EZW MEDTRONIC NEUROMODULATION 3889 0204428452

    Patients

    Seq Age Sex Outcome Treatment
    1