BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3880671 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11737
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    June 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37744, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD TO HAVE A SECOND OPERATION BECAUSE, HIS LEADS MOVED. ONE LEAD WENT UP HIS BACK AND ONE LEAD WENT DOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE IN THE BACK DIDN¿T WORK; IT WOULDN¿T CHARGE OR CONNECT TO THE CONTROLLER. THE WIRES WERE ALSO CAUSING A BURNING FEELING IN THE BACK WHEN SLEEPING BECAUSE THEY WERE BEING PULLED ON FROM MOVEMENT IN SLEEP. PAIN OF SURGERY WAS MENTIONED. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356993 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 00037 YR Required Intervention