BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3951528 · Received July 23, 2014

    Report

    Report Number
    3007566237-2014-02041
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ITB PATIENT RECENTLY SHOWED OVERDOSAGE AND UNDERDOSAGE SYMPTOMS. THE PUMP SEEMED TO FUNCTION NORMAL (NO VOLUME DISCREPANCY AND NORMAL PUMP LOGS. IT WAS EXPECTED THAT THE CATHETER WAS NOT ¿OK.¿ ADDITIONAL TESTS WERE TO BE PERFORMED TO CHECK THE CATHETER INTEGRITY VIA THE CATHETER ACCESS PORT (CAP). IT WAS THOUGHT THAT THE CATHETER WAS ¿PRETTY OLD¿ AND CONSIDERATION OF CATHETER REPLACEMENT WAS MADE. THIS DEVICE SYSTEM DELIVERED BACLOFEN. IT WAS FURTHER REPORTED THAT AFTER TROUBLESHOOTING THE PATIENT RECEIVED ORAL BACLOFEN AND VALIUM. THE PHYSICIAN DECIDED TO REPLACE THE CATHETER ¿LAST WEEK.¿ AFTER EXPLANT, NOTHING APPEARED AS TO WHERE THE ISSUE WITH THE CATHETER WAS AND THEREFORE THE ISSUE WAS NOT IDENTIFIED. THE PATIENT WAS REPORTED TO BE ¿OK FOR THE MOMENT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432062 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention