BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3183078 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10734
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 2, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# V621113, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION WITH SYMPTOMS OF INCREASED FREQUENCY OF GRAM NEGATIVE BACTERIAL CYSTISIS. AN INFECTIOUS DISEASE CONSULT INDICATED THAT IT HAD WORSENED SINCE DEVICE PLACEMENT. THE PATIENT WAS ADMINISTERED CEFEPIME 1 GM IV X¿S 1, VANCOMYCIN 2000MG, Q 18HRS IV FROM (B)(6) 2013, AZREONAM 1GM IV TID FROM (B)(6) 2013 AND CEFPODOXIME 200MG PO BID X¿S 7 DAYS. THIS WAS CONCURRENT WITH TREATMENT FOR ASPIRATION PNEUMONIA. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282616 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention