BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1910722 · Received November 22, 2010

    Report

    Report Number
    3007566237-2010-09854
    Event Type
    Injury
    Date Received
    November 22, 2010
    Report Date
    November 11, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP WORKED WELL FOR THE FIRST MONTHS, THEN SUDDENLY, PUS STARTED COMING OUT FROM THE PUMP RESERVOIR SITE. AS THE PT'S DAUGHTER PUSHED HARDER AND HARDER, MORE PUS CAME OUT; SOMETIMES THE PUS WAS MIXED WITH BLOOD. THIS CONTINUED FOR 4 MONTHS. DURING THAT TIME, THE PT'S DAUGHTER ASKED THE HOSPITAL TECH IF THIS WAS NORMAL AND "HE SAID IT'S NOTHING, IT'S NOTHING." EVENTUALLY, THE PT'S DAUGHTER CONTACTED THE PHYSICIAN AND THE PHYSICIAN SAW HER MOTHER. THE PHYSICIAN STATED THAT IT WAS "VERY DANGEROUS" AND THE PT WAS TAKEN TO SURGERY THE NEXT DAY. THE PHYSICIAN EXPLANTED THE PUMP, CLEANED THE PUMP IMPLANT SITE, AND RE-IMPLANTED THE SAME PUMP CONTRA LATERALLY. THE PT WAS GIVEN ANTIBIOTICS. THE PT RECOVERED. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    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 Required Intervention