BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2061788 · Received March 30, 2011

    Report

    Report Number
    3004209178-2011-02413
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INS (IMPLANTABLE NEURO STIMULATOR) WAS NOT IN A GOOD PLACE; IT WAS MOVING BACK AND FORTH IN THE PATIENT'S BUTTOCKS. THE STIMULATION WASN'T WORKING AS WELL DURING THE DAY; THE PATIENT HAD TO TAKE MEDICATION WHICH RESOLVED THE ISSUE. IT WAS NOTED THAT NIGHT WAS GOOD BUT WHEN THE PATIENT STANDS UP "IT ALL GOES DOWN HER LEG". THE PATIENT WAS EXPERIENCING LOSS OF BLADDER CONTROL AND A SHOCKING OR JOLTING SENSATION. THE PATIENT WAS AT HOME IN FAIR CONDITION AT THE TIME OF THE REPORT. THE MANUFACTURER'S REPRESENTATIVE CALLED THE PATIENT AND INSTRUCTED THE PATIENT TO TURN OFF THE STIMULATOR UNTIL SHE SEES THE HCP ON (B)(6) 2011. THE PATIENT HAD LOST SOME WEIGHT; THE IMPLANT SITE WAS NOW LOWER AND IN A POSITION WHERE THE PATIENT WAS SITTING ON IT. THEY WERE CONSIDERING REMOVING/REVISING THE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH039514V| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V100937| PROGRAMMER: MODEL 3031A, LOT# NGM026896P| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH039514V| EXPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM026896P| IMPLANTED:| LEAD: MODEL 3093, LOT# V100937