BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3901835 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12256
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# VA0K1B1, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UN KNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO IDEA HOW TO USE THE PATIENT PROGRAMMER AND THEY WERE NOT ABLE TO COMMUNICATE WITH AND WITHOUT THE ANTENNA ATTACHED. TODAY WAS THE FIRST TIME THEY TRIED USING THE PROGRAMMER AND THEY WERE NOT ABLE TO TRY REPOSITIONING THE ANTENNA BECAUSE THEY WERE IN PUBLIC. IT WAS NOTED THAT THEY WERE GOING TO TRY AGAIN LATER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THEY WERE NOT ABLE TO MAKE ADJUSTMENT BOTH WITH AND WITHOUT THE ANTENNA ATTACHED. THEY ONLY GOT THE POOR COMMUNICATION SCREEN ON THE PROGRAMMER WHEN TRYING TO SYNC. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED IN THE UPPER BUTTOCK AND THE PATIENT STILL HAD A CLEAR BANDAGE OVER THE INCISION SITE. THEY HAD MOVED THE ANTENNA ALL OVER AND TRIED WITHOUT THE ANTENNA AS WELL AND STILL GOT THE POOR COMMUNICATION SCREEN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THEY WANTED TO KNOW WHEN THE PROGRAMMER WAS OFF IF THE INS WAS OFF AS WELL. THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND HAD A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THAT THEY CHANGED FROM PROGRAM 3 AT 0.8V TO PROGRAM 4 AT 5.4V AND THE PATIENT FELT LIKE THEY WERE BEING ELECTROCUTED. THEY WERE NOT ABLE TO TURN THE STIMULATION DOWN SO THEY CHANGED IT BACK TO PROGRAM 3. IT WAS REPORTED THAT THE INS WAS NOT HELPING THE PATIENT WITH THEIR SYMPTOMS SINCE HAVING IT AND THEY WERE NOT ABLE TO SYNC BECAUSE THEY WERE NOT SURE WHERE THE INS WAS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNKNOWN IF THERE WAS 50 PERCENT OR GREATER SYMPTOM REDUCTION. THE COMPONENT INVOLVED IN THE REPORTED EVENT WAS THE PROGRAMMER. IT WAS NOTED THAT THE PATIENT AND THEIR DAUGHTER COULDN¿T GET IT TO CONNECT WITH THE IMPLANT. THE ACTION TAKEN TO RESOLVE THE ISSUE WAS THAT THE PATIENT AND THEIR DAUGHTER WERE INSTRUCTED ON HOW AND WHERE THE IMPLANT WAS. IT WAS REPORTED THAT THE EVENT WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380783 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Other