BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4243849 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21343
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 23, 2014
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: NEU_UNKNOWN_EXT, LOT# SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NOT FELT STIMULATION IN TWO DAYS. IT WAS NOTED THAT THE PATIENT WAS IN REHAB. THE PATIENT WAS IN GROUP (A) AT 1.0 VOLTS, AND WAS "AT 0.20". THE HEALTHCARE PROVIDER (HCP) INCREASED STIMULATION ABOVE 1.0 VOLT, AT SOME POINT AND THE STIMULATION WAS HURTING HER UNTIL IT WAS TURNED DOWN. AT THE END OF THE REPORT, THE PATIENT HAD THE STIMULATION THAT SHE NEEDED; THE ACTION RESOLVED THE REPORTED ISSUE. INFORMATION REGARDING IF THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726380 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR