BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4002202 · Received August 12, 2014

    Report

    Report Number
    3004209178-2014-15151
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Report Date
    July 17, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE ANALYSIS FOR INS NKF713544H REVEALED SERVICE LIFE STARTED PREMATURELY .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INS HAD NOT BEEN IMPLANTED IN THE PATIENT, IT WAS STILL IN THE BOX. THE COMPANY REPRESENTATIVE WAS GETTING THE INS READY FOR A SURGERY, TRIED TO CHARGE IT AND IT WOULD NOT COMMUNICATE WITH THE CHARGER. TWO CHARGERS AND TWO 8840¿S (CLINICIAN PROGRAMMER) WERE TRIED TO INTERROGATE OR COMMUNICATE WITH THE BATTERY AND IT WOULD NOT COMMUNICATE WITH EITHER PROGRAMMERS OR CHARGERS. THE DEVICE WAS GOING TO BE RETURNED TO THE DEVICE MANUFACTURER. IT WAS ADDITIONALLY REPORTED THAT THE CHARGING SYSTEM WAS NOT COUPLED WITH THE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480521 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