BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3102644 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07438
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 24, 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 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD BEEN IMPLANTED 21 DAYS PAST ITS EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204537 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1