BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2802677 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09456
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    September 25, 2012
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # V060172, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A DEVICE REPLACEMENT THE DAY PRIOR TO REPORT. THE PREVIOUS DEVICE "DIDN'T WORK RIGHT." ONE OF THE ELECTRODES DIDN'T WORK. ONE OF THE PROGRAMS CAUSED A LOT OF PAIN, ANOTHER WOULD CAUSE PAIN INCREASING FROM .90 V TO .95 V, AND ANOTHER "DIDN'T WORK VERY WELL." THE PATIENT HAD MET WITH MANUFACTURER'S REPRESENTATIVE FOR ADJUSTMENTS, HOWEVER RESULTS OF THE ADJUSTMENTS WERE NOT REPORTED. THE IMPLANT "GRADUALLY STOPPED BEING EFFECTIVE" A FEW MONTHS BEFORE A NEW IMPLANT AS PLACED, AND THE DEVICE WAS "MORE ANNOYING" FOR THE YEAR PRECEDING THE REPLACEMENT. THE PATIENT HAD A FEW FALLS DURING THE MONTHS THAT LED TO THE DEVICE NOT WORKING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention