BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2544777 · Received April 23, 2012

    Report

    Report Number
    3004209178-2012-02584
    Event Type
    Injury
    Date Received
    April 23, 2012
    Report Date
    April 9, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377760, LOT # V003347, SERIAL # IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYPE LEAD, PRODUCT ID 3777-60, LOT # SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYPE LEAD, PRODUCT ID 37752, LOT # SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYPE RECHARGER, PRODUCT ID 37742, LOT # SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYPE PROGRAMMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION AND ACUTE PAIN. ALSO NOTED WERE DIFFICULTIES WALKING AND LOSS OF BALANCE. THE SYMPTOMS OCCURRED FOLLOWING A FALL. THE PATIENT FELL AT THE END OF (B)(6) 2011. THE PATIENT WAS THEN IN A COMA FOR APPROX 9 WEEKS AFTER THE FALL. THE PATIENT HAD NOT HAD THE DEVICE TURNED ON OR CHARGED SINCE. THE PATIENT'S DEVICE HAD NOT BEEN CHECKED SINCE THEN. THE LOCATION OF THE PATIENT'S SYMPTOMS WAS LEFT AND RIGHT LEG AND BACK. THE PATIENT WAS AT HOME. WHAT IS THE PATIENT LOCATION? HOME. A LOST OR STOLEN PATIENT DEVICE WAS NOTED. THE FOLLOWING REPLACEMENT DEVICE WAS ORDERED FOR THE PATIENT: INSR. THE PATIENT WAS IN CONTACT WITH HER HEALTHCARE PROFESSIONAL AND HAD AN APPOINTMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other