BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3942192 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13196
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# V872545, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3093-28, LOT# V872545, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INDICATED A WEEK AGO PRIOR TO CALL PATIENT STARTED HAVING A BRUISE LIKE PAIN BUT IT WAS STILL HURTING. IT WAS INDICATED THAT PATIENT WOULD BE MEETING WITH THE HEALTH CARE PROVIDER A DAY AFTER THIS REPORT TO CHECK THEIR DEVICE. THE PATIENT WANTED TO TURN STIM OFF UNTIL SHE SEES HCP THE DAY AFTER THIS CALL. THE PATIENT STATED THAT THE MANUFACTURE REPRESENTATIVE THOUGHT THE WIRE MAYBE DISLODGED BUT NOT SURE. THERE WAS NO FALL OR TRAUMA REPORTED. THE PATIENT WAS HURTING PRETTY BAD AND WANTED IT TURN OFF. THE PATIENT ASSISTED AND THE DEVICE WAS TURNED OFF. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419813 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR