BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3055218 · Received April 12, 2013

    Report

    Report Number
    3004209178-2013-06088
    Event Type
    Injury
    Date Received
    April 12, 2013
    Report Date
    March 25, 2013
    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
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # V913912, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED ON (B)(6) 2012 THAT THE PATIENT HAD PAIN IN THE LOWER BACK AND BUTTOCK AREA. THE PATIENT'S LEGS WERE "NUMB AND TINGLY" AND HE WAS "LOSING HIS ABILITY TO WALK." THE PATIENT WENT TO THE EMERGENCY ROOM (ER) THE NIGHT PRIOR AND X-RAYS SHOWED NOTHING WAS WRONG WITH HIM. THE PATIENT WAS SCREAMING IN PAIN AND THE HEALTH CARE PROVIDERS (HCP) DID NOT KNOW IF SOMETHING HAD BROKEN LOOSE FROM THE DEVICE. THE ER HCP HAD NEVER WORKED WITH THESE DEVICES BEFORE, BUT SAID IT DID NOT LOOK LIKE IT WAS IN THE RIGHT AREA. THE PATIENT ALSO WENT TO HIS OTHER HCP IN (B)(6) AND COMPLAINED OF A BROKEN AND LOOSE ANCHOR. THIS HCP REPORTEDLY STATED THAT THE PATIENT NEEDED TO DEAL WITH THE PAIN AS LONG AS HE CAN AND GAVE HIM EXCUSES. THE DEVICE DID WORK BEFORE THIS NEW SEVERE PAIN AROSE. THERE WERE NO RELATED FALLS OR ACCIDENTS. ABOUT TWO MONTHS LATER, IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS "MOVEMENT." IT WAS NOT CLEAR WHAT MOVEMENT THIS WAS. AN IMAGE OF THE LEAD SHOWED THAT IT HAD NOT MOVED. THERE WAS NO INTERVENTION OR HOSPITALIZATION. A MONTH AND A HALF LATER, IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) WANTED TO MOVE THE LEADS TO ASSIST WITH PAIN CONTROL. THE LEAD WAS MOVED ON (B)(6) 2013 TO THE RIGHT SIDE. THE PATIENT HAD BEEN DOING WELL SINCE THE LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157195 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention