BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2993364 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03466
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# VA04V0L, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SAW A MANUFACTURER REPRESENTATIVE AT THEIR HEALTH CARE PROVIDER'S OFFICE TO ADJUST STIMULATION. IT WAS STATED THAT THE PATIENT REPORTS SHE HAD A URINARY INFECTION AND WAS PLACED ON ANTIBIOTICS. IT WAS STATED THAT THE PATIENT IS "URINATING MORE NOW THAN EVER BEFORE." IT WAS NOTED THAT THE PATIENT'S MANUFACTURER REPRESENTATIVE INFORMED THE PATIENT THAT HE COULD NOT GET AN ACCURATE "READING" WHILE SHE HAS THE INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97445 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention