BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3556037 · Received January 6, 2014

    Report

    Report Number
    3004209178-2014-00234
    Event Type
    Injury
    Date Received
    January 6, 2014
    Date of Event
    December 16, 2013
    Report Date
    December 16, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V940070, IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF STIMULATION/THERAPEUTIC EFFECT AND THE LEAD WAS REPLACED. THE IMPEDANCES WERE MEASURED, X-RAYS WERE TAKEN, AND THE PATIENT WAS REPROGRAMMED. IT WAS ALSO STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) SEEMED TO MIGRATE TOWARD THE SKIN. THE INS WAS MOVED TO THE LEFT SIDE. IT WAS FURTHER STATED THAT THE PATIENT EXPERIENCED EROSION, PAIN, REDNESS, SWELLING, AND HAD LESS THAN 50% RELIEF. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERAPEUTIC EFFECT WAS NO LONGER BEING MAINTAINED AND THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5528 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention