BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3875227 · Received June 16, 2014

    Report

    Report Number
    3004209178-2014-11645
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    May 27, 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. PRODUCT ID NEU_PTM_PROG, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER (HCP) NEEDED A COMPANY REPRESENTATIVE TO COME AND DO AN ADJUSTMENT ON THE PATIENT. THE PATIENT WAS NEW TO THE HCP AND WAS IMPLANTED ABOUT A YEAR AGO. ¿IT¿ HAS NOT BEEN WORKING FOR THE PATIENT SINCE IT WAS ADJUSTED IN (B)(6) OF 2012. THE PATIENT HAS AN APPOINTMENT ON (B)(6), 2014. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352272 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1