BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 3871174 · Received June 13, 2014

    Report

    Report Number
    3007566237-2014-01629
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3982, SERIAL# (B)(4), IMPLANTED: 1995-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 7433, SERIAL# (B)(4), IMPLANTED: 1995-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 7496-51, SERIAL# (B)(4), IMPLANTED: 1995-(B)(6), EXPLANTED: 2007-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S SYSTEM WAS EXPLANTED ONE PIECE AT A TIME IN MULTIPLE SURGERIES. IT WAS NOTED THE EXPLANT WAS DUE TO THE DEVICE TOUCHING THE WRONG PART OF THE SPINAL NERVE AND IT BEING A DANGEROUS SPOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350976 ITREL II STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7424

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention