BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERSTIM GENERATOR

    MDR report key: 3763734 · Received April 16, 2014

    Report

    Report Number
    MW5035733
    Event Type
    Death
    Date Received
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THERE ARE TREMENDOUS COMPLAINT'S OF THE INTERSTIM MADE BY MEDTRONIC. IT WORKS LIKE A PACE MAKER. IT KILLED MY MOTHER AND I HAVE SPOKE TO MANY OTHERS THAT HAVE EXPERIENCED, SHOCKS, JOLTS, EVEN BURN SPOTS, AND DISLODGEMENT AT THE IMPLANT SITE. OTHERS EXPERIENCED SEVERE PAIN. THE STIMULATION IS PROGRAMED AT THE DOCTOR'S OFFICE AND PTS HAVE A GENERATOR. THERE HAS BEEN NOTHING BUT HORROR STORIES OF BEING SHOCKED TO DEATH. PEOPLE HAVE ALSO HAD IT REMOVED BECAUSE OF THE COMPLICATIONS AND STILL EXPERIENCE PAIN. INTERSTIM OR SNS THERAPY INCLUDING THE GENERATORS / NEUROMODULATORS NEED TO BE INVESTIGATED. THIS DEVICE HAS BEEN A NIGHTMARE FOR MANY PEOPLE WITH THE ELECTRICAL PULSES, ZAPS, SHOCKS, JOLTS, TOO PAINFUL AND UNABLE TO MOVE AND HAVE EXPERIENCED DEATH FROM THE STIMULATIONS, WIRES AND LEADS. PLEASE DO SOMETHING. IT SEEMS PEOPLE ARE ELECTROCUTED FROM THE INSIDE OUT AND HAVE SEEN SOME INSURANCE PAY UP TO (B)(6) JUST FOR THE TRIAL PROCEDURE. PRICES VARY BASED ON THE INSURANCE. IT KILLED MY MOTHER AND OTHERS AS WELL AS LIFELONG INJURIES IN OTHER PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232290 INTERSTIM GENERATOR INTERSTIM GENERATOR LGW MEDTRONIC
    232291 LEADS LEADS DTB MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death