BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4242502 · Received November 11, 2014

    Report

    Report Number
    3007566237-2014-03288
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    August 28, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3898 SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NOT BEEN FEELING IT WAS NECESSARY TO USE THEIR STIMULATION. THE PATIENT¿S PAIN CAME BACK AND THEY STARTED TO USE STIMULATION AGAIN BUT IT WAS NOT WORKING, THEIR PAIN WAS NOT RELIEVED. THE PATIENT ALSO HAD INAPPROPRIATE STIMULATION AND THE PAIN RESTARTED. THE LEAD HAD MOVED HOWEVER THE PATIENT DID NOT HAVE ANY PAIN FROM THE LEAD THAT HAD MOVED. ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED ¿SECURING THE LEAD¿ APRIL 25, 2014. THE PATIENT ALSO WISHED TO HAVE SURGERY FOR A NEW LEAD IMPLANT. THE EXPLANT AND REPLACEMENT WAS ON (B)(6) 2014. THE PATIENT WAS ALSO HOSPITALIZED FROM (B)(6) 2014. IT WAS UNKNOWN IF ANY DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS DONE. THE PATIENT WAS ¿STIMULATED¿ IN ALL AREAS, THIGH, CALF, AND LUMBAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727175 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| R