BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3364176 · Received September 24, 2013

    Report

    Report Number
    3004209178-2013-16823
    Event Type
    Malfunction
    Date Received
    September 24, 2013
    Report Date
    February 25, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3987A, LOT# N174771, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3987A, LOT# N183268, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37083-20, SERIAL#(B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37083-20, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOT OF PAIN IN THE LEG. IT WAS NOTED THAT THE PATIENT¿S STIMULATOR WAS BURNING ¿AT THE SITE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483033 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1