BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6146315 · Received December 5, 2016

    Report

    Report Number
    3004209178-2016-25191
    Event Type
    Injury
    Date Received
    December 5, 2016
    Report Date
    December 5, 2016
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V940070, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PATIENT REPORTED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT WORKING PROPERLY. THEY WERE NOT GETTING THE STIMULATION THEY HAD BEEN GETTING PREVIOUSLY. THE HEALTHCARE PROVIDER (HCP) DID X-RAYS AND NOTICED THE ELECTRODES WERE NOT IN THE RIGHT POSITION. THE HCP DID NOT KNOW IF IT WAS DUE TO THE IMPLANT PROCEDURE OR IF IT SHIFTED OVER TIME. THE PATIENT STATED IT WAS GRADUAL OVER TIME. THE PATIENT STATED THAT THE INS AND THE LEAD WERE REPLACED TO RESOLVE THE ISSUE. THE INS WAS INDICATED FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION/GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796774 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention