BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4130332 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-18016
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 9, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V838980, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAS HAD TROUBLE WITH ITCHING ALL OVER HER BODY, NERVOUSNESS AND BEING UPTIGHT ALONG WITH EXTREME PAIN WITH HER RIGHT LEG IF IT WAS NOT STRAIGHT WHILE LAYING DOWN AND AT THE INS (STIMULATOR) SITE WHEN SHE LAYS DOWN AT NIGHT. THIS HAS BEEN OCCURRING FOR MONTHS AND A LONG TIME . THE ONSET WAS GRADUAL. IT WAS NOTED 1.5 MONTHS AGO THE PATIENT WAS DIAGNOSED WITH A UTI (URINARY TRACT INFECTION) AFTER SHE HAD LAB WORK DONE SO SHE WAS PUT ON A "ONE TIME ANTIBIOTIC" TO CLEAR UP THE INFECTION. SHE SAW THE NEW HCP (HEALTHCARE PROVIDER) 3 WEEKS AGO AND WAS ADVISED TO TURN OFF THE INS FOR 2 DAYS TO SEE IF THE SYMPTOMS SUBSIDED. PREVIOUS TO THIS OFFICE VISIT IT HAD BEEN OVER A YEAR SINCE THE LAST TIME SHE HAD SEEN HER HEALTHCARE PROVIDER. THE PATIENT HAS HAD THE INS OFF FOR 3 WEEKS AND THE PAIN, NERVOUSNESS AND BEING UPTIGHT WENT AWAY ALTHOUGH THE ITCHING WAS STILL AN ISSUE. THE PATIENT THOUGHT THE ITCHING MAY BE DUE TO DRY SKIN BECAUSE, WHEN SHE LATHERS HER SKIN WITH LOTION IT GETS BETTER. PATIENT THINKS THE OTHER SYMPTOMS MAY BE DUE TO THE DEVICE LAYING ON PATIENT¿S NERVES FOR HER LEGS. SHE HAS NOT FELT STIMULATION FOR A LONG TIME WHEN SHE HAD THE INS ON BUT THE URINARY SYMPTOMS GOT BETTER. THE PATIENT WANTS TO TURN THE INS BACK ON BECAUSE IF SHE WASN¿T RIGHT BY A BATHROOM SHE HAS SYMPTOM ISSUES. THE PATIENT SUCCESSFULLY TURNED HER INS BACK ON. SHE FELT A LITTLE PULSE WHEN IT WAS TURNED ON AND CHANGING FROM PROGRAM 2 AT 2.45 TO 2.65 WHERE SHE COULD FEEL THE STIMULATION MAINLY IN HER BUTTOCK TO PROGRAM 1 FROM 2.65 TO 2.50 AND COULD THEN FEEL THE STIMULATION IN HER VAGINA AND BUTTOCK AREA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606807 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention