BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4231613 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21055
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 15, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# VA0MMM7, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# VA0EEBE, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS HELPING WITH THEIR BOWEL PROBLEMS MORE THAN THEIR URINARY PROBLEMS. THE PATIENT DID STATE LATER THAT THE STIMULATOR WAS HELPING THEM. THE PATIENT STATED THAT ¿IT TURNS ITSELF OFF ALL OF THE TIME.¿ IT WAS NOTED THAT IT HAD DONE THIS SEVERAL TIMES SINCE IMPLANT AND THE PATIENT¿S DOCTOR THOUGHT IT WAS FROM WALKING THROUGH THE METAL DETECTOR. THE PATIENT STATED IT HAD ONLY HAPPENED ONCE SINCE THEIR LEAD REVISION IN (B)(6) 2014. IT WAS NOTED THAT IN (B)(6) 2014, THE PATIENT WAS AT A CONCERT AND WHEN THE SECURITY PEOPLE USED THEIR WAND IT TURNED IT OFF. THE PATIENT STATED THEY KNEW WHEN IT WAS OFF BECAUSE THEIR SYMPTOMS CAME BACK. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713893 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR