BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE

    MDR report key: 3241753 · Received July 22, 2013

    Report

    Report Number
    3007566237-2013-02438
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A DUAL WIRE TRIAL FROM (B)(6) 2013 AND IT WAS REMOVED. IT WAS NOTED THAT THE TRIAL DID NOT WORK WELL BECAUSE IT MOVED AND THE PATIENT WILL BE TRYING THE SINGLE WIRE TRIAL SOON. FOLLOW-UP INFORMATION RECEIVED REPORTED THE CAUSE OF EVENT AS INCONCLUSIVE TEST (PNE) AND ATTRIBUTED THE EVENT TO THE LEAD. THE ISSUE WITH THE LEAD WAS NOTED AS ¿UNKNOWN ¿ PT. REPORTED DISCOMFORT WITH STIMULATION.¿ IT WAS NOTED THAT THIS WAS A TRIAL (PNE) TEST AND NOT A STAGED TEST OR IMPLANT. THE PATIENT DID NOT REQUIRE HOSPITALIZATION, AND THE PATIENT OUTCOME WAS REPORTED AS NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340159 FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1