BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4232980 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21097
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 4, 2013
    Report Date
    October 16, 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 Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S DEVICE HAD ¿LOCKED UP¿ ON THEM BEFORE. THE PATIENT MEANT THE LEADS HAD SHIFTED. THE LEADS SHIFTED AS THE PATIENT WAS TRYING TO GET OUT OF A CHAIR AND THE INTENSITY WENT UP. THERE SEEMED TO HAVE BEEN A LITTLE BIT OF ¿PLAY¿ WHEN THE PATIENT MOVED. THE ISSUES WERE NOTED TO HAVE OCCURRED SINCE IMPLANT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THE PHYSICIAN OR MANUFACTURER REPRESENTATIVE (REP). THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714655 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR