BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3011306 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03926
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    March 5, 2013
    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 MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# V004442V01, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT FOOT SURGERY AND STOPPED USING THE DEVICE. ADDITIONALLY, DUE TO THIS NON-USE, SHE STOPPED CHARGING THE DEVICE IN (B)(6) 2012, RESULTING IN AN OVERDISCHARGE. THE DEVICE HAD ATTEMPTED TROUBLESHOOTING WITHOUT LUCK, AND RESULTED IN BATTERY REPLACEMENT. THE PATIENT'S STATUS WAS REPORTED AS ALIVE AND WITHOUT INJURY OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113678 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 00044 YR Required Intervention