BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3864900 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11388
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V360690, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NOTED A LOST OR STOLEN PATIENT DEVICE. THE FOLLOWING REPLACEMENT DEVICE WAS ORDERED FOR THE PATIENT: PATIENT PROGRAMMER. ANTENNA. THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. THE PATIENT LOST URINARY RELIEF 3 MONTHS AGO, BUT SHE COULDN'T ADJUST STIM. SINCE SHE LOST HER PATIENT PROGRAMMER. THE PATIENT WENT TO HCP (HEALTHCARE PROVIDER) AND THE NURSE ADJUSTED STIM. 2 WEEKS AGO ON FRIDAY. AS RESULT THE PATIENT'S URINARY ISSUE GOT WORSE. THE PATIENT WAS USING HEAVY PAD AT NIGHT AND WAS WETTING THE BED. ALSO, THE NURSE USED A CATHETER TO CHECK THE PATIENT'S BLADDER. THE PATIENT ENDED UP HAVING A KIDNEY INFECTION. THE PATIENT HAD BEEN IN THE ER TWICE AND HOSPITAL ONCE FOR HER INFECTION, AND SHE HAD URINE IN HER BLOOD. ALSO, SINCE THE NURSE ADJUSTED STIM, THE PATIENT WAS JERKING ALL OVER THE PLACE. HER KNEE AND LEGS GIVE OUT AND HER ARMS SWING OUT. THE PATIENT SAID THE NURSE DIDN'T THINK IT WAS RELATED BUT THEY WERE CHECKING. THE PATIENT WAS TO SEE THE NURSE TOMORROW TO TURN THE IMPLANT OFF. THE PATIENT SAW HER HCP ON MONDAY. FINALLY, THE PATIENT SAID INS HAD MOVED AND SHE WAS SITTING ON TOP OF THE IMPLANT. THE PATIENT DIDN'T KNOW WHEN IT MOVED; SHE SAID "LIKE IT CAME OUT OF THE POCKET". IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339859 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R