BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2585343 · Received May 23, 2012

    Report

    Report Number
    3004209178-2012-03634
    Event Type
    Malfunction
    Date Received
    May 23, 2012
    Report Date
    April 26, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3888-33, LOT# V096187, IMPLANTED: 2008 (B)(6), LEAD MODEL 3888-33, LOT# V020235, IMPLANTED: 2008 (B)(6), LEAD MODEL 3778-60, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), RECHARGER MODEL 37752, SERIAL# (B)(4), PROGRAMMER MODEL 37743, SERIAL# (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POWER ON RESET (POR) CONDITION AROUND EASTER RESULTING IN TELEMETRY ISSUES. AROUND THE SAME TIME, THE PATIENT WAS UNABLE TO TURN STIMULATION ON AND HAD A FALL. THE REASON FOR THE POR WAS UNKNOWN AND THE PATIENT'S BATTERY WAS NEAR OVERDISCHARGE. USE OF THE ANTENNA LOCATOR RESULTED IN A POR CONDITION DISPLAYED ON THE PATIENT PROGRAMMER, WHICH LED TO A NORMAL RECHARGING SCREEN. THE PATIENT RECEIVED 8 BARS OF COUPLING AND WAS TO RECHARGE THE DEVICE SO THAT THE POR COULD BE CLEARED. THE PATIENT HAD NOT RECEIVED ADEQUATE STIMULATION, SO IMPEDANCES WERE TO BE CHECKED AND THE PROGRAMMING OPTIMIZED. THE PATIENT ALSO HAD A FALL AROUND THIS TIME BUT THEY WERE UNABLE TO CONNECT THE TWO EVENTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS HAVING A DIFFICULT TIME GETTING THE SYSTEM TO WORK. IT WAS REPORTED THAT THE PATIENT SPENT 30 MINUTES WORKING WITH A MANUFACTURER REPRESENTATIVE ON (B)(4) 2012, AND GOT IT TO WORK. THERE WAS NO HOSPITALIZATION, NO INJURY, A NON-SERIOUS ILLNESS / INJURY, AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    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