BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2761163 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-08572
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    August 28, 2012
    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

    PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POWER-ON-RESET (POR) CONDITION AND TELEMETRY ISSUES. IT WAS UNABLE TO DO TELEMETRY. PHYSICIAN CHARGE MODE WAS STARTED ON THE DAY OF THIS REPORT. PATIENT DID RECHARGE LAST THURSDAY AND HE WOULD NORMALLY CHARGE FROM HALF TO FULL EVERY 2-3 DAYS. ANTENNA LOCATE TEST WAS PERFORMED AND A POR MESSAGE WAS SEEN. IMPLANTABLE NEUROSTIMULATOR STARTED TO CHARGE NORMALLY. IT WAS LATER REPORTED THAT POR WAS PERFORMED AND STIMULATION RETURNED. PATIENT WAS DOING FINE.

    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