BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2580161 · Received May 18, 2012

    Report

    Report Number
    3004209178-2012-03474
    Event Type
    Malfunction
    Date Received
    May 18, 2012
    Report Date
    May 1, 2012
    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 Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377760, LOT # V010769, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. PRODUCT ID 377760, LOT # V013515, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER. PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT FOR THE PAST SIX MONTHS THE PATIENT HAS EXPERIENCED A RUBBER BAND SENSATION AROUND HER LOWER RIB WHICH WAS HARDLY NOTICEABLE. THE RUBBER BAND SENSATION WAS FELT FROM THE LEAD INCISION SITE ALL THE WAY AROUND HER LOWER RIBS WHILE LAYING ON HER BACK. THERE HAS BEEN NO TRAUMA OR FALLS IN ASSOCIATION. THE LEADS AS THEY COME OUT OF HER BACK HAVE BEEN MOVING. SHE NEVER TURNS OFF HER STIMULATION SO SHE DID NOT KNOW IF TURNING THE STIMULATION OFF WOULD RESOLVE THE ISSUE BUT WOULD TRY. THERE HAVE BEEN NO CHANGES IN THERAPY AND THE OVERALL THERAPY WAS WORKING QUITE WELL FOR HER. SHE HAD AN APPOINTMENT WITH HER DOCTOR ON (B)(6) 2013 TO DISCUSS THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT HAD NO CONCERNS WITH THEIR DEVICE THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN WHICH STARTED YESTERDAY; IT FELT LIKE IT WAS A T10 AREA. THE PATIENT COULD SEE SOMETHING UNDER THE SKIN. IT LOOKED LIKE A MOVEMENT OF THE LEADS. IT WAS PAINFUL WHEN THE PATIENT LAY DOWN. THE SYSTEM WAS WORKING. THE PATIENT WAS CONCERNED ABOUT HER BACK. THE LEAD WAS OUTLINED. THERE WAS NO REDNESS OR SWELLING. THE PATIENT WAS RECHARGING AT THE TIME AND IT FELT LIKE IT WAS A BUNCH OF BED LINEN UNDER HER. THE PATIENT COULD FEEL THE LEAD GOING TO THE BACK TO THE BASE OF THE STIMULUS. THE PATIENT'S HUSBAND COULD SEE SOMETHING. THE ISSUE JUST HAPPENED LAST NIGHT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR