BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3770597 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08070
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 4, 2014
    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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION IN LEFT LEG, SO A REVISION WAS PERFORMED. ANOTHER LEAD WAS ADDED TO THE SYSTEM WITH INTRA-OP TESTING PERFORMED TO OBTAIN APPROPRIATE STIMULATION COVERAGE. DIAGNOSTIC TESTING OR TROUBLESHOOTING PERFORMED INCLUDED IMPEDANCE TESTING, X-RAYS, AND REPROGRAMMING. IMPEDANCES WERE WITHIN NORMAL RANGE, BOTH PRE AND POST OPERATIVE. IT WAS STATED THAT ONE TAIL OF THE SURGICAL LEAD REMAINED CONNECTED TO THE BATTERY. THE ISSUE WAS RESOLVED, BUT THE CAUSE OF THE ISSUE WAS UNKNOWN BUT IT WAS STATED THAT THE PATIENT HAD TAKEN A FALL PRIOR TO LOSING STIMULATION IN THE AFFECTED AREA IN (B)(6) 2014. IT WAS LATER REPORTED THAT THE PATIENT WAS GETTING EXCELLENT COVERAGE POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249683 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention