BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA CATHETER

    MDR report key: 921629 · Received September 21, 2007

    Report

    Report Number
    6000030-2007-02822
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Report Date
    September 27, 2006
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION NUMBER WHICH COVERS A 2-YEAR RETROSPECTIVE REVIEW OF REPORTED EVENTS INVOLVING CATHETERS AND EVENTS REPORTED BY CONSUMERS BETWEEN 2005 AND 2006 (INCLUSIVE). THIS EXEMPTION WAS GRANTED TO SATISFY MEDTRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY, DEATH AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS 461 PREVIOUSLY UNREPORTED MALFUNCTION EVENTS FOR INTRATHECAL CATHETERS; 165 MALFUNCTION EVENTS FOR MODEL 8709, 50 MALFUNCTION EVENTS FOR MODEL 8709AA, 74 MALFUNCTION EVENTS FOR MODEL 8731, 40 MALFUNCTION EVENTS FOR MODEL 8711, 52 MALFUNCTION EVENTS FOR MODEL 8703W, 45 MALFUNCTION EVENTS FOR MODEL CATHETER, 12 MALFUNCTION EVENTS FOR MODEL 8596, 9 MALFUNCTION EVENTS FOR MODEL 8598, 6 MALFUNCTION EVENT FOR MODEL 8703, 4 MALFUNCTION EVENTS FOR MODEL 8575, AND 4 MALFUNCTION EVENTS FOR MODEL 8516 FOR THE ABOVE TIME PERIOD (ALL PRODUCT CODE LKK). THIS TOTAL INCLUDES THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED, HE HAD AN X-RAY TWO MONTHS AGO THAT REVEALED THE CATHETER WAS DISCONNECTED AT THE PUMP CONNECTOR SITE; HOWEVER IT MAY HAVE BEEN STILL CONNECTED TO THE CONDUIT. THE MANUFACTURER'S TECHNICAL SERVICE REDIRECTED THE PATIENT TO HIS PHYSICIAN FOR MEDICAL DIRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER LKK RICE CREEK MANUFACTURING 8709 L54314

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other EXPLANTED| IMPLANTABLE INFUSION PUMP MODEL 8627L18 | IMPLANTED| LOT# NGH023212R| IMPLANTABLE INFUSION PUMP MODEL 8627L18| IMPLANTED| LOT# NGH023212R| EXPLANTED