BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2985364 · Received March 1, 2013

    Report

    Report Number
    3004209178-2013-03206
    Event Type
    Injury
    Date Received
    March 1, 2013
    Report Date
    September 13, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-39, LOT# N267543, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 3550-29, LOT# N260112, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A BROKEN LEAD AFTER SHE HAD A FALL 'A LONG TIME AGO.' THE LEAD 'WAS NOT CONNECTED TO ANYTHING,' SO IT WAS REVISED. IT WAS ALSO STATED MORE RECENTLY, 'ABOUT TWO WEEKS AGO,' THE PATIENT HAD A FALL AND SINCE THE FALL IT ONLY TOOK HER 15-20 MINUTES TO CHARGE HER IMPLANTABLE NEUROSTIMULATOR (INS), WHEN IT USED TO TAKE ONE TO TWO HOURS. THE PATIENT WAS REDIRECTED TO HER HEALTHCARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88818 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 Required Intervention