BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3163094 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10168
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 31, 2013
    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

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 8840, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE MANUFACTURE REPRESENTATIVE HAD TRIED TO "TAKE A READING ON IT" AND WAS JUST GETTING THE SYMBOL ON THE MACHINE "WHERE THERE'S NO RESPONSE." IT WAS REPORTED THAT "THE BATTERY WAS JUST TOO LOW." IT WAS REPORTED THAT THE MANUFACTURE REPRESENTATIVE GOT THE SAME MESSAGE ON THE PATIENT PROGRAMMER, "IT¿S GIVING LIKE THE SAME THING, WHERE I CAN'T FIND IT AND LITERALLY LIKE RIGHT OVER THE DEVICE."

    Description of Event or Problem · 1

    IT WAS STATED THE IMPLANTABLE NEUROSTIMULATOR (INS) SHUT OFF ON (B)(6) 2013 AND NO TELEMETRY FROM EXTERNAL COMPONENTS INCLUDING THE PHYSICIAN PROGRAMMER, THE PATIENT PROGRAMMER, AND RECHARGER WERE ESTABLISHED. USE OF ANTENNA LOCATE (AL) RESULTED IN POWER ON RESET (POR) DISPLAYED, WHICH LEAD TO THE NORMAL RECHARGING SCREEN. IT WAS NOTED THE PATIENT RECEIVED EIGHT BARS OF COUPLING. PATIENT SYMPTOMS WERE NOT REPORTED. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263785 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 00056 YR