BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3902639 · Received June 30, 2014

    Report

    Report Number
    3007566237-2014-01823
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97740, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID NEU _UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NIGHT PRIOR TO REPORT THE PATIENT STOPPED FEELING STIMULATION. IT WAS NOTED THAT THERE WAS NO STIMULATION SENSATION. THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT WAS UNABLE TO COMMUNICATE WITH THE PATIENT PROGRAMMER. IT WAS NOTED THAT THE ISSUE BEGAN ON THE DATE OF REPORT AND SHE WAS ABLE TO USE IT PREVIOUSLY. THE PATIENT ASKED WHAT SHE NEEDED TO SEE ON THE SCREEN TO FEEL THE VIBRATIONS. IT WAS VERIFIED THE PATIENT WAS PLACING THE PADDLE DIRECTLY OVER THE IMPLANT. THE PATIENT SATED THAT THEY STILL HAD BANDAGES ON THE INCISION SITE. IT WAS NOTED THAT THE PATIENT WAS ONLY GETTING THE POOR COMMUNICATION INFORMATION SCREEN. PATIENT SERVICES HAD THE PATIENT RECONNECT WITHOUT THE ANTENNA. THE POOR COMMUNICATIONS SCREEN WAS NOTED. IT WAS REVIEWED WITH THE CALLER THAT THERE MAY BE POCKET SWELLING WHICH COULD RESULT IN DIFFICULTY FOR SUCCESSFUL COMMUNICATION BETWEEN INS AND PATIENT PROGRAMMER. THE CALLER STATED SHE DID NOT WANT TO WAIT A FEW DAYS FOR THE HEALING PROCESS AND WOULD LIKE TO USE HER STIMULATOR. THE PATIENT NOTED THAT THEY WERE ABLE TO COMMUNICATE PREVIOUSLY. THERE WERE NO FALLS OR TRAUMA REPORTED. THE CALLER ASKED FOR A MANUFACTURER REPRESENTATIVE TO SPEAK WITH THEM. IT WAS LATER REPORTED BY THE HEALTHCARE PROFESSIONAL (HCP) THAT THE CAUSE OF EVENT WAS DETERMINED AND IT WAS NOT DEVICE RELATED. IT WAS NOTED THAT THE PATIENT DID NOT KNOW HOW TO USE THE PROGRAMMER. IT WAS NOTED THAT THE DATE OF THE MEETING WAS (B)(6) 2014 AND THERE WAS NO REPROGRAMMING NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380140 UNKNOWN NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1