BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2990268 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03339
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 12, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39286-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL ABOUT 4 FEET BACKWARDS OFF A TRUCK AND HIT HIS HEAD. IT WAS STATED THAT THE PATIENT THINKS HE PULLED ONE OF HIS WIRES LOOSE. IT WAS NOTED THAT THE PATIENT CURRENTLY DOES NOT HAVE A HEALTH CARE PROVIDER (HCP) BUT WANTED A MANUFACTURER REPRESENTATIVE TO CHECK THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THAT DIAGNOSTICS WERE PERFORMED AND EVERYTHING WAS "WORKING PROPERLY". IT WAS NOTED THAT THE PATIENT WAS REPROGRAMMED. IT WAS ALSO STATED THAT THE PATIENT WAS "FINE AND RECEIVING EFFECTIVE THERAPY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93077 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 00064 YR