BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1051759 · Received May 21, 2008

    Report

    Report Number
    3004209178-2008-02720
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    February 1, 2008
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SKIN INFECTION HAD DEVELOPED AFTER DEVICE IMPLANT; THE PT WAS INFORMED OF THE DIAGNOSIS AT FOLLOW-UP, TWO WEEKS AFTER SURGERY. THERE HAD INITIALLY BEEN ADEQUATE STIMULATION THERAPY CONTROL, THE PT WAS UNABLE TO USE STIMULATION THERAPY THREE WEEKS AFTER PLACEMENT. THE PT INDICATED THAT PAIN SYMPTOMS HAD SUBSEQUENTLY INCREASED FROM THE INFECTION, WHICH HAD PROGRESSED TO THE VERTEBRAE LOCATED AT "G+7." THE CAUSATIVE ORGANISM WAS MRSA. THE DEVICE WAS EXPLANTED AND THE PT WAS HOSPITALIZED FOR ONE WEEK, PRIOR TO DISCHARGE TO HOME. IT WAS UNK IF THE SYSTEM WAS REMOVED; DEVICE TRACKING DOES NOT INDICATE PRODUCT REMOVAL. THE PT OUTCOME SHOWED RECOVERY WAS ONGOING; TWO AREAS OF TISSUE DAMAGE (TWO LARGE HOLES), REMAINED IN THE PT'S BACK. THE PT WAS UNABLE TO RETURN TO WORK. ADD'L INFO HAS BEEN REQUESTED FROM THE PHYSICIAN.

    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 Hospitalization| R LEAD MODEL 39565 LOT# N129611006| IMPLANTED:| EXPLANTED:| EXTENSION MODEL 37081 LOT# NJB024121V| IMPLANTED:| PROGRAMMER MODEL 37742 LOT# NJD061312N| ACCESSORY MODEL 37752 LOT# NKA033081N| EXTENSION MODEL 37081 LOT# NJB023854V| IMPLANTED:| EXPLANTED:| EXPLANTED: