BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNYCHROMED EL

    MDR report key: 1132591 · Received August 22, 2008

    Report

    Report Number
    6000030-2008-05171
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    January 1, 2007
    Report Date
    July 24, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0956-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO ANOMALY FOUND - NORMAL DEVICE FUNCTION. RESULTS: DRUG WITH BLACK MATTER PULLED FROM THE CATHETER DURING PUMP REPLACEMENT. THIS WAS SENT BACK FOR ANALYSIS, BUT NO RESULTS HAVE BEEN REPORTED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE PT REPORTED THAT IN 2008, SHE HAD AN MRI, THE PUMP WAS INTERROGATED AFTER THE PROCEDURE AND SHE WAS FINE. SHE COMPLAINED OF OVERDOSE SYMPTOMS THAT REQUIRED 24 HR HOSPITALIZATION AND PUMP PROGRAMMING UPDATES IN MULTIPLE OCCASIONS STARTING ONE WEEK AFTER THE MRI (2007 AND 2008). AFTER THE 3RD INCIDENCE, THE PUMP WAS REMOVED AND REPLACED. THE PT STATED THAT SHE IS DOING VERY WELL SINCE THE IMPLANT OF THE NEW PUMP. THE HEALTH PROVIDER REPORTED THAT THE PT WAS SEEN IN 2007, FOR A LUMBAR STEROID INJECTION. DURING THE REFILL VISIT THE FOLLOWING MONTH, IT WAS NOTED THAT THE PT WAS RECENTLY HOSPITALIZED FOR FLU SYMPTOMS. THE NEXT TWO REFILLS WERE IN 2007 AND 2008. THERE WAS NO MENTION OF ANY PROBLEMS OR RECENT HOSPITALIZATIONS AT THE TIME. THE PT WAS HOSPITALIZED IN 2008, DUE TO INCREASED SEDATION. NO CHANGES IN ORAL MEDICATIONS WERE NOTED. IT WAS FELT THAT THE PUMP WAS MALFUNCTIONING. THE PUMP WAS INTERROGATED AND NO PROBLEMS WERE FOUND. THERE WERE NO ALARMS. THE PUMP WAS REPLACED. SOME BLACK PARTICULATE MATTER WAS FOUND IN THE REMAINDER OF DRUG PULLED FROM THE CATHETER DURING REPLACEMENT. THE PT RECOVERED AND RETURNED PERIODICALLY FOR SCHEDULED REFILLS. THE PUMP WAS USED TO DELIVER MORPHINE, COMPOUNDED BACLOFEN AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SNYCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R IMPLANTED| PROGRAMMER MODEL PROGRAMMER| CATHETER MODEL 8709| EXPLANTED