BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4231990 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21061
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 13, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 7427V, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. PRODUCT ID: 377760, LOT# V006389, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 377760, LOT# V006389, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY "POOPED OUT" AND STOPPED DUE TO "NORMAL" BATTERY DEPLETION. THE INS WAS REPLACED FOUR DAYS AFTER THE INITIAL REPORT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS "HAPPY" NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715071 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention