BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3181622 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10684
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3998 LOT# V118064, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37082-40 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD THEIR STIMULATOR REMOVED TWO WEEKS PRIOR BECAUSE THE LEAD WAS CAUSING THEM PAIN. IT WAS NOTED THERE WAS A LUMP/RAISED SKIN WHICH HAD CAUSED THEM PAIN SINCE 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282909 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention