BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2930944 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01013
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE DIFFICULTIES ADVANCING THE LEAD INTRA-OPERATIVELY, MAKING IT IMPOSSIBLE TO PLACE THE LEAD ENTIRELY INTO THE EPIDURAL SPACE. AS A RESULT, THE LOWER ELECTRODES WERE NOT IN THE EPIDURAL SPACE. IT WAS NOTED THAT THERE WERE PROBLEMS WITH SCAR TISSUE. THE REPORTER ALSO INDICATED THAT HIGH IMPEDANCES WERE MEASURED ON ELECTRODES 6 AND 7. HOWEVER, NO TROUBLESHOOTING WAS PERFORMED. THERE WERE NO PATIENT SYMPTOMS AND THE PATIENT HAD GREAT STIMULATION AND COVERAGE POST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37986 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1