BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1800558 · Received August 12, 2010

    Report

    Report Number
    3007566237-2010-06077
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 15, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    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

    IT WAS REPORTED THE PATIENT BLED A LOT AT LEAD INTRODUCER SITE; IT SATURATED SEVERAL PADS AND TOTALED "A COUPLE OF CUPS." A NURSE PRACTITIONER LATER ASSESSED THE PATIENT'S INSERTION SITE AND THE BLEEDING HAD SUBSIDED AND THE WOUND WAS REDRESSED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION 3625 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD: MODEL 3889, LOT# UNK| EXPLANTED:| IMPLANTED: