BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3142496 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08535
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 13, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3708320, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3986A70, LOT# N266627, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) SEEMED TO BE MOVING AND ¿GETTING CLOSER TO THE SURFACE.¿ IN THE PAST WEEK ONE CORNER WAS TENDER TO THE TOUCH. IT WAS NOTED THE PATIENT¿S THERAPY HAD NOT CHANGED AND ¿THINGS SEEMED TO BE WORKING FINE.¿ THE PATIENT WAS ¿UNCOMFORTABLE AT THE POCKET SITE.¿ IT WAS NOTED THE PATIENT HAD A DOCTOR¿S APPOINTMENT SCHEDULED (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED TWO DAYS LATER REPORTED THE PATIENT SAW HER PHYSICIAN AND HE RECOMMENDED WAITING BECAUSE THE PATIENT HAD ONLY HAD THE PAIN ONE WEEK. THE PATIENT WAS TO FOLLOW UP WITH HER PHYSICIAN IF ANYTHING WORSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244505 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1