BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3191374 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10935
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V027287, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ONE UNEXPECTED DEVICE RELATED VISIT TO THE HEALTH CARE PROVIDER (HCP) OR HOSPITAL. IT WAS ALSO NOTED THAT THE PATIENT SENT A POSITIVE RESPONSE REGARDING A DEVICE RELATED HOSPITALIZATION ¿AND/OR¿ URINARY TRACT INFECTION. CARE WAS SOUGHT AT THE ¿IMPLANT SITE¿ AND NO URINARY TRACT INFECTION WAS NOTED. THREE DAYS LATER IT WAS REPORTED THAT THE PATIENT HAD BLADDER PRESSURE ¿ALL NIGHT.¿ THE PATIENT WAS GOING TO THE BATHROOM EVERY FIVE TO TEN MINUTES. THE PATIENT NOTED THAT SHE ¿CANNOT EAT CABBAGE,¿ AS IT CAUSED HER PRESSURE, AND THE GREEN SALAD SHE ATE MUST HAVE HAD ¿ROMAINE IN IT.¿ THE PRESSURE AND URGENCY PROBLEM CONTINUED FOR ¿THE REST OF THE WEEK.¿ ON (B)(6) 2013 THE HEALTH CARE PROVIDER (HCP) DID A CULTURE AND URINE TEST. NO INFECTION OR BACTERIA GROWTH WAS SEEN. ON (B)(6) 2013 THE HCP ¿UPGRADED THE PATIENT¿S PROGRAMMER.¿ THE HCP ALSO DID A BLADDER INJECTION OF HORMONE MEDICATION AND HEALING AGENT. THE HCP ALSO STARTED A PRESCRIPTION OF ¿ESTRACE¿ THAT THE PATIENT WAS TO USE TWICE A WEEK. THE HCP STATED THAT IT ¿WOULD TAKE SEVERAL DAYS FOR THE BLADDER TO GET BACK IN SHAPE AGAIN.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CLINICAL DIAGNOSIS WAS URINARY TRACT INFECTION (UTI). IT WAS NOTED THAT THE DIAGNOSTIC TYPE WAS LABORATORY TESTING WHICH SHOWED ABNORMAL INFORMATION THAT CAME FROM AN OUTSIDE SOURCE. IT WAS NOTED THAT IT WAS NOT RELATED. IT WAS NOTED THAT THE ACTIONS TAKEN INCLUDED AN UNSCHEDULED CLINIC OR OFFICE VISIT. IT WAS NOTED THAT MEDICATIONS WERE ADMINISTERED AND THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291438 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R