BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3360001 · Received September 20, 2013

    Report

    Report Number
    3004209178-2013-16666
    Event Type
    Injury
    Date Received
    September 20, 2013
    Date of Event
    February 1, 2009
    Report Date
    February 15, 2017
    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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V141293, IMPLANTED: 2008 (B)(6), EXPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITH THE PATIENT¿S FIRST IMPLANTABLE NEUROSTIMULATOR (INS), THE PATIENT EXPERIENCED TOE CURLING AND SHOCKING. IT WAS STATED THAT THE PATIENT EXPERIENCED SHOCKING 6 MONTHS AFTER THE MANUFACTURER REPRESENTATIVE MENTIONED THAT ¿SOMETHING MUST BE BROKEN.¿ THE INS WAS REPLACED IN 2012.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THEY HAD HORRIBLE PAIN WHEN THE DEVICE WAS PLACED. IT WAS FURTHER REPORTED THE CONSUMER¿S FIRST IMPLANT BROKE SO THEY HAD TO HAVE IT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475535 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Required Intervention