BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 4

    MDR report key: 3112373 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07650
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-28, LOT# J0225319V, IMPLANTED: 2003-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: 2003-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LEAD REVISION ON (B)(6)-2013. IT WAS STATED THE LEAD WAS REPLACED AND THE STATED THE SYSTEM WAS WORKING. IT WAS LATER REPORTED THE EXTENSIONS WERE GOOD, AND THE PATIENT RECEIVED EFFECTIVE THERAPY FOLLOWING THE LEAD REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213222 ITREL 4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37703

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention