BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3925650 · Received July 10, 2014

    Report

    Report Number
    3004209178-2014-12781
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 18, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # VA0J8G1, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME INTO THEIR HEALTH CARE PROVIDER¿S (HCP¿S) OFFICE TODAY FOR REPROGRAMMING. THE PATIENT FELT A POKING SENSATION THAT WAS CAUSING THEM TO SIT SIDEWAYS ON ONE SIDE. IT WAS NOTED THAT THIS WAS IN THE LOCATION OF TO THE RIGHT AND OVER THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT TURNED OFF THE THERAPY FOR THE PAST WEEK AND THE POKING SENSATION WENT AWAY. IT WAS REPORTED THAT THEY WERE USING THE MANAGE BY FACT (MBF) PROTOCOL AND ALL 4 PROGRAMS USING THE BIPOLES GAVE THE POKING SENSATION SINCE IMPLANT. USING C POSITIVE AND 0 NEGATIVE THE PATIENT FELT A SHOCKING SENSATION, USING C POSITIVE AND 3 NEGATIVE THE PATIENT FELT STIMULATION IN THE TAILBONE AT A LOW LEVEL, AND USING C POSITIVE AND 1 NEGATIVE THE PATIENT FELT STIMULATION AT 0.2V IN THE VAGINAL AREA AT PULSE WIDTH 240 AT 14 HZ WITH CYCLING ON. IT WAS NOTED THAT THE PATIENT WAS NOT FEELING THE POKING SENSATION WITH THAT PROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404243 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR