BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1181204 · Received September 30, 2008

    Report

    Report Number
    3004209178-2008-06231
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TE PATIENT HAD COMPLICATIONS SINCE THE SYSTEM WAS IMPLANTED. THE PATIENT HAD EXTREME WEAKNESS ON THE RIGHT SIDE OF HIS BODY, AS WELL AS OTHER COMPLICATIONS WHICH WERE NOT SPECIFIED. THE LEAD WAS AT THE CERVICAL LEVEL. THE PATIENT WAS IN THE REHAB UNIT OF THE HOSPITAL. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization EXPLANTED| RECHARGER MODEL 37752| PROGRAMMER MODEL 37743| EXPLANTED| LEAD MODEL 3998| EXTENSION MODEL 37082