BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3851404 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10177
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3889-28, LOT# VA0C2C9, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED THAT SHE WAS ALWAYS ON THE ROAD FOR WORK AND COULD NOT BE LOOKING FOR A BATHROOM ALL THE TIME. THE PATIENT HAD A LOSS OF BLADDER CONTROL AND ¿FULLNESS.¿ THE PATIENT STATED THAT PRIOR TO IMPLANT ¿SHE WOULD USE THE RESTROOM AND THEN TEN MINUTES LATER, HER BLADDER WAS READY TO EXPLODE AGAIN.¿ THE PATIENT NOTED THAT SHE FELT THE THERAPY DID WORK AS ¿HER BLADDER DID NOT FEEL AS FULL AT TIMES.¿ HOWEVER, THE PATIENT WENT ON TO STATE THAT THERAPY WAS NO LONGER HELPING AND SHE FELT ¿FULL, DRIP, OR NOTHING.¿ THE PATIENT MENTIONED THAT SHE HAD A URINARY TRACT INFECTION (UTI) AND WAS ON CIPRO. THE PATIENT NOTED THAT THIS ¿MADE HER FEEL BETTER AND SHE WAS FEELING GOOD,¿ BUT WAS UNSURE IF IT WAS THE ANTIBIOTIC OR THE DEVICE THAT MADE HER FEEL BETTER. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328661 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention