BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2973171 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02974
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    February 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# V855145, IMPLANTED: (B)(6) 2011. PRODUCT TYPE LEAD; PRODUCT ID 3998, LOT# V855145, IMPLANTED: (B)(6) 2011, PRODUCT TYPE; LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 3550-29, LOT# N293627, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY; (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONALE INFORMATION STATED THE PATIENT HAD STIMULATION TURNED OFF BECAUSE ¿SOMETIMES IT MADE IT WORSE THAN BETTER.¿ IT WAS NOTED THE PROGRAMMER WAS ¿UNABLE TO READ THE BATTERY. IT WAS REPORTED THE PATIENT SAW A ¿POOR COMMUNICATION¿ SCREEN ON THE PROGRAMMER. IT WAS NOTED THE PATIENT HAD NOT RECHARGED FOR A WEEK. IT WAS NOTED AFTER THE POR WAS CLEARED, THE PATIENT¿S BATTERY LEVEL WAS AT HALF.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COULD NOT ADJUST STIMULATION. A POWER ON RESET (POR) CONDITION WAS REPORTED WITHOUT A DIAGNOSTIC IDENTIFIER. PROVIDING PATIENT PROGRAMMER OPERATION INFORMATION RESOLVED THE ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76080 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 00046 YR