BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1132597 · Received August 22, 2008

    Report

    Report Number
    3004209178-2008-05173
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    April 30, 2008
    Report Date
    July 28, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PT WAS GOING TO HAVE A THIRD LEAD REVISION THE DAY OF THE COMPLAINT. DEVICE TROUBLESHOOTING INFO WAS NOT REPORTED. THE PT WAS AT HOME AT THE TIME OF THE COMPLAINT; HER STATUS WAS REPORTED A 'GOOD'. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE ELECTRODES WERE REPOSITIONED TO A DIFFERENT LEVEL IN THE SPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention EXPLANTED| EXPLANTED| LEAD MODEL 3777 LOT # V090738007 IMPLANTED| LEAD MODEL 3777 LOT # V090738008 IMPLANTED| PROGRAMMER MODEL 37742 LOT # NJD027627N| LEAD MODEL 3777 LOT # V090738008 IMPLANTED| EXPLANTED| PROGRAMMER MODEL 37742 LOT # NJD027627N| EXPLANTED| LEAD MODEL 3777 LOT # V090738007 IMPLANTED