BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRATHECAL

    MDR report key: 1011621 · Received March 10, 2008

    Report

    Report Number
    2182207-2008-01188
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Report Date
    May 9, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VALLEJO, R. ET AL. "MORPHINE PUMP CATHETER RUPTURE AFTER PERCUTANEOUS LITHOTRIPSY" WORLD INSTITUTE OF PAIN. 2006; 6,4:289-290. SIX MOS AFTER IMPLANTATION, THE PT STARTED TO COMPLAIN OF SEVERE INTERMITTENT ABDOMINAL PAIN THAT RADIATED TO HER RIGHT GROIN AND WAS ASSOCIATED TO HEMATURIA. THE PT WAS DIAGNOSED WITH KIDNEY STONES AND UNDERWENT PERCUTANEOUS LITHOTRIPSY. SEVERAL DAYS AFTER THE LITHOTRIPSY, THE PT REPORTED SEVERE WORSENING OF HER LOW BACK PAIN. ATTEMPTS TO INCREASE THE RATE OF INFUSION DID NOT PROVIDE ANY RELIEF, SO PUMPOGRAM WAS PERFORMED WHICH INDICATED EXTRUSION OF CONTRAST INTO THE SUBCUTANEOUS TISSUES. THE PT WAS TAKEN TO THE OR, AND A NEW CATHETER WAS IMPLANTED. TWO WEEKS FOLLOWING REPLACEMENT, THE PT WAS AGAIN OBTAINING ADEQUATE PAIN RELIEF USING A BASAL INFUSION RATE OF HYDROMORPHONE. NO SIGNS OF OVERDOSE WERE REPORTED BY THE PT AFTER THE LITHOTRIPSY, OTHER THAN THE REBOUND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRATHECAL LKK MEDTRONIC NEUROMODULATION CATHETER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention PROGRAMMER MODEL 8840 LOT # UNK| IMPLANTED| EXPLANTED| IMPLANTED| IMPLANTABLE INFUSION PUMP MODEL 8637| EXPLANTED