BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4161968 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19418
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT # VA0FMYC, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED NEVER HAD THERAPEUTIC EFFECT. THE PATIENT INDICATED THAT IT HAD BEEN SO LONG IT HAD NOT HELPED. THE PATIENT INDICATED THAT SHE HAD URGE INCONTINENCE AT THE URINE CAME OUT GUSHING RATHER THAN A STREAM AND IT WAS MUCH WORSE AT NIGHT, FLOWS OVER THE URINE CUP AND THROUGH 3 SOAKED PADS. THE PATIENT TYPICALLY FELT STIMULATION HOWEVER HAD NOTICED AFTER A WHILE SHE HAD TO TURN DOWN LOWER IF IT STARTED TO FEEL SORE. THE PATIENT FELT THE PULSE NOT ON LEFT SIDE OF VAGINA HOWEVER THAT WAS THE SAME SIDE SHE HAS A CYST. THE PATIENT REPORTED THAT HER URINE WAS VERY CONCENTRATED AND DARK HAD A STRONG ODOR BUT NOT A URINE ODOR. THE PATIENT HAD BEEN EATING A LOT OF RED BEETS FROM HER GARDEN BUT IT HAD BEEN A FEW DAYS SINCE SHE HAD EATEN ANY. IT WAS LATER REPORTED ON (B)(6) 2014 THAT SINCE THE PATIENT¿S IMPLANT, THE PATIENT HAD NOT SEEN A DIFFERENCE IN SYMPTOMS. THE PATIENT FELL ON (B)(6) 2014; HOWEVER, THE MANUFACTURER REPRESENTATIVE DID NOT ATTRIBUTE THE FALL TO THE DEVICE, BECAUSE THE PATIENT HAD UNSUCCESSFUL THERAPY FROM THE START. MANUFACTURER REPRESENTATIVE STATED THERE WAS NOTHING TECHNICALLY WRONG WITH THE DEVICE; THE DEVICE DID NOT WORK THE PATIENT AND THE PATIENT HAS SEVERAL OTHER MEDICAL ISSUES. MANUFACTURER REPRESENTATIVE REPORTED THE PATIENT WAS SEEN AT THE HEALTH CARE PROVIDER¿S OFFICE ON THE DAY OF THIS CALL, (B)(6) 2014, AND A URINARY TRACT INFECTION WAS FOUND. ADDITIONALLY, THE PATIENT HAD AN ULTRASOUND ON (B)(6) 2014 WHERE SMALL STONES WERE IDENTIFIED IN THE PATIENT¿S KIDNEY AND THESE MEDICAL ISSUES COULD POTENTIALLY HAVE CAUSED THE PATIENT¿S URGE INCONTINENCE. THE MANUFACTURER REPRESENTATIVE STATED THE PATIENT HAD BEEN REPROGRAMMED THREE TIMES. THE FIRST TIME WAS ABOUT A MONTH AFTER THE IMPLANT AND WAS DONE OVER THE PHONE. THE MANUFACTURER REPRESENTATIVE STATED SHE WALKED THE PATIENT THROUGH REPROGRAMMING OVER THE PHONE. THE SECOND REPROGRAMMING SESSION TOOK PLACE IN THE HEALTH CARE PROVIDER¿S OFFICE BUT PERFORMED BY MANUFACTURER REPRESENTATIVE. THE THIRD SESSION WAS ON THE DAY OF THIS CALL AND PERFORMED BY THE STAFF AT THE OFFICE. THE MANUFACTURER REPRESENTATIVE STATED THE PATIENT NEEDED TO REMEDIATE THESE MEDICAL ISSUES BEFORE FURTHER TROUBLE SHOOTING WOULD BE POSSIBLE. IT WAS INDICATED THAT THE PATIENT TO CONTINUE WITH THE CURRENT SETTINGS FOR A COUPLE OF WEEKS. THE MANUFACTURER REPRESENTATIVE STATED THE PATIENT CONTACTED HER ABOUT A MONTH AFTER IMPLANT BECAUSE THE PATIENT WAS NOT GETTING THE RELIEF THE PATIENT WANTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643784 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Required Intervention