BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOMED

    MDR report key: 2032473 · Received March 25, 2011

    Report

    Report Number
    3007566237-2011-02306
    Event Type
    Injury
    Date Received
    March 25, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P990034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS INVOLVED IN A HEAD ON COLLISION RIGHT AFTER IMPLANT. AFTER THE SCAB FELL OFF THE INCISION "GREEN STUFF CAME OUT". THE PT NEEDED TO HAVE SURGERY TO "REMOVE THE ROTTED TISSUE FROM THE PUMP." IT WAS ALSO REPORTED THAT FOLLOWING A FALL ON (B)(6), THE PT WAS ABLE TO MOVE HIS PUMP FROM SIDE TO SIDE ABOUT 4-5 INCHES. THE PUMP WAS USED TO DELIVER FENTANYL AND HYDROMORPHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOMED LKK MEDTRONIC NEUROMODULATION 8472-35-05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention CATHETER: MODEL 8711, LOT# L78727| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# L78727| EXPLANTED:| IMPLANTED: