BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3344601 · Received September 12, 2013

    Report

    Report Number
    3004209178-2013-16103
    Event Type
    Malfunction
    Date Received
    September 12, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3550-39, LOT# N267543, IMPLANTED: 2011 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3550-29, LOT# N260112, IMPLANTED: 2011 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A DECREASE IN RECHARGING TIME. IT WAS STATED AFTER THE PATIENT FELL 2 WEEKS PRIOR IT ONLY TOOK 15-20 MINUTES TO RECHARGE WHEREAS PRIOR IT TOOK HER 1-2 HOURS. IT WAS NOTED THE PATIENT HAD NOT HAD HER DEVICE CHECKED AFTER THE FALL 2 WEEKS PRIOR. IT WAS NOTED PATIENT HAD PRIOR FALL WITH A LEAD BREAK, SEE MANUFACTURING REPORT 3004209178-2013-03206.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460065 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 00057 YR