BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2588476 · Received May 25, 2012

    Report

    Report Number
    3004209178-2012-03725
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Report Date
    April 26, 2012
    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
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748940, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: NA, PRODUCT TYPE EXTENSION. PRODUCT ID 748940, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: NA, PRODUCT TYPE EXTENSION. PRODUCT ID 74002, LOT # N230111, IMPLANTED: (B)(6) 2011, EXPLANTED: NA, PRODUCT TYPE POCKET. ADAPTOR PRODUCT ID 399930, LOT # J0455119V, IMPLANTED: (B)(6) 2005, EXPLANTED: NA, PRODUCT TYPE LEAD. PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING SENSATION AND INADEQUATE PAIN RELIEF. THE PATIENT FELT A SHOCKING SENSATION WHEN HE LAID DOWN. THE PATIENT ALSO REPORTED THAT A FEW MONTHS AGO THE IMPLANTABLE NEUROSTIMULATOR (INS) STOPPED HELPING HIS RIGHT LEG PAIN. THERE WAS NO TRAUMA OR FALL ASSOCIATED WITH THE LOSS OF THERAPY. THE PATIENT ALSO NOTED THAT HE WAS UNABLE TO TURN THE STIMULATION OFF. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1