BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2655223 · Received July 13, 2012

    Report

    Report Number
    3004209178-2012-05595
    Event Type
    Malfunction
    Date Received
    July 13, 2012
    Report Date
    June 15, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: LEAD: MODEL 3487A-45, LOT# V495239, IMPLANTED: (B)(6) 2011, EXPLANTED: NA. LEAD: MODEL 3487A-45, LOT# V210748, IMPLANTED: (B)(6) 2011, EXPLANTED: NA. LEAD: MODEL 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: NA. EXTENSION: MODEL 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: NA. PROGRAMMER: MODEL 37743, SERIAL# (B)(4). RECHARGER: MODEL 37752, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO COMMUNICATE WITH PATIENT PROGRAMMER AND INSR. THE PATIENT EXPERIENCED COUPLING AND OR COMMUNICATION ISSUES. USE OF THE ANTENNA LOCATE FEATURE RESULTED IN A POWER-ON-RESET (POR) MESSAGE BEING DISPLAYED ON THE RECHARGER, WHICH THEN LEAD TO THE NORMAL RECHARGING SCREEN. THE PATIENT WAS THEN ABLE TO SEE ALL 8 COUPLING BARS. THE PATIENT PLANNED TO CHARGE THE INS TO FULL, AND THEN CLEAR THE POR MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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