BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2893304 · Received January 2, 2013

    Report

    Report Number
    3004209178-2013-00049
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    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

    PRODUCT ID, 3998 LOT# V810876, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708240 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT LOST THE ABILITY TO MOVE THEIR LEFT LEG/FOOT AFTER THE PROCEDURE. AFTER "AT LEAST ONE DIAGNOSTIC TEST" WAS PERFORMED, IT WAS DETERMINED THE PATIENT SUFFERED A HERNIATED DISC IN THEIR THORACIC SPINE. IT WAS UNCLEAR WHICH TEST WAS CONDUCTED. IT WAS NOTED THE PHYSICIAN WANTED TO REPOSITION THE LEAD, BUT THE PATIENT WANTED "IT OUT." IT WAS INDICATED THE SYSTEM WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. PAIN BEHIND THE LEFT KNEE WAS ALSO REPORTED AS A SYMPTOM. THREE DAYS LATER, IT WAS REPORTED THE PATIENT WAS "FINE NOW." NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention