BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4791392 · Received May 22, 2015

    Report

    Report Number
    3007566237-2015-01402
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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 MEDICAL PRODUCTS: 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

    IT WAS REPORTED THAT THE STIMULATION WAS UNABLE TO BE ADJUSTED. THE DISPLAY ON THE PATIENT PROGRAMMER (PP) WAS SHOWING THE ¿CALL YOUR DOCTOR¿ ICON AND A 574 CODE. THE DAY OF THE REPORT WAS THE FIRST TIME THIS CODE WAS SEEN. IT WAS REVIEWED WITH THE MANUFACTURER¿S REPRESENTATIVE (REP) THAT EITHER THE IMPLANTABLE NEUROSTIMULATOR (INS) WASN¿T PROPERLY INITIALIZED BY THE CLINICIAN PROGRAMMER OR THE PROGRAMMING HAD BEEN LOST. THE REP. WAS ABLE TO CHECK WITH THE CLINICIAN PROGRAMMER AND CONFIRMED THIS WAS THE CASE. THE REP. DID CHANGE SOME SETTINGS WITH THE PROGRAMMER TO TRY AND TROUBLESHOOT AND NOTED SHE WOULD ADD THE PROGRAMMING BACK IN. THE REP. CONFIRMED THE PP WAS NOW WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334219 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 97714

    Patients

    Seq Age Sex Outcome Treatment
    1