BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1910465 · Received November 18, 2010

    Report

    Report Number
    3007566237-2010-09753
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    May 11, 2010
    Report Date
    November 10, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT CAME IN FOR A PUMP REFILL. BEFORE THE PHYSICIAN FILLED THE PUMP, THE PHYSICIAN SAW INFLAMMATION OF THE PUMP. THE PT WAS HOSPITALIZED. THE NEXT DAY, THE PUMP WAS EXPLANTED DUE TO INFECTION. IT WAS NOTED THAT THE PT REMEMBERED HAVING LOCAL PAIN AT THE PUMP SITE IN EARLY (B)(6); THE PHYSICIAN FELT THAT THE PAIN WAS PROBABLY NORMAL POSTOPERATIVE PAIN. THE PT WAS TREATED WITH IV CEFOTAXIN AND ORAL OSPEN. THE PT RECOVERED AS OF (B)(6) 2010. THE PHYSICIAN PLANNED TO REEVALUATE THE PT 3 MONTHS POST EXPLANT FOR ANOTHER PUMP IMPLANT. THE DEVICE SYSTEM WAS USED TO DELIVER PRIALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R