BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4090528 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17053
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO CONNECT HIS LEFT STIMULATOR TO HIS PROGRAMMER OR RECHARGER. HE HAD BEEN HAVING TROUBLE CHARGING THE LEFT IMPLANT SINCE THE WEEK PRIOR. THE PATIENT WAS ABLE TO CHARGE AND USE THE PROGRAMMER ON THE RIGHT IMPLANT. A POWER ON RESET (POR) OCCURRED AT ONE POINT, BUT THE RECHARGER STOPPED SINCE HE COULDN¿T GET COUPLING. FOLLOW UP INDICATED THAT THE PATIENT RECEIVED A NEW RECHARGER BELT AND HAD NO FURTHER CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569884 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 00075 YR