BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3010002 · Received March 18, 2013

    Report

    Report Number
    3007566237-2013-00825
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    November 12, 2012
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PAIN OVER THE INCISION AND STATED "THERE'S A LUMP THERE." IT WAS NOTED THAT THE PATIENT THOUGHT THE LUMPS WERE JUST SWELLING. IT WAS STATED THAT THE PATIENT DEVELOPED AN INFECTION AND HAD TO TAKE ANTIBIOTICS. IT WAS LATER STATED THAT THE LUMPS AND INFECTION HAD HEALED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113002 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3625

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention