BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3821741 · Received May 20, 2014

    Report

    Report Number
    3007566237-2014-01372
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8551, LOT# CS3613, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN USED AN AFFECTED KIT BUT THERE WAS NOT A PROBLEM. THE RECALLED BOX WAS IDENTIFIED BUT DID IT WAS NOT SEND BACK BECAUSE THE PHYSICIAN HAD ALREADY USED IT AND DISCARDED IT. THERE WAS REPORTEDLY "NO PROBLEM" HERE EVEN THOUGH THE BOX WAS ONE THAT SHOULD HAVE BEEN PULLED OFF THE SHELF AND THE PHYSICIAN WAS NOTIFIED. THE PATIENT HAD PAIN MEDICATIONS IN HER PUMP, DOSE AND CONCENTRATION WERE NOT KNOWN AT THIS TIME. THERE WERE NO PATIENT SYMPTOMS AND NO STUDIES NEEDED TO BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO ASPIRATE 40 CC OF DRUG AT A PUMP REFILL BUT EXPECTED ON A FEW CC¿S. THE INTERROGATION OF THIS PUMP DID NOT HAVE ANY LOGS THAT READ THERE WAS A PROBLEM. THIS PATIENT WAS GOING FOR FURTHER ANALYSIS (I.E. ROTOR STUDY) TO SEE WHY THE DRUG WAS NOT PUMPING OUT THE DRUG. IT WAS NOT PROVIDED WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED. IT WAS FURTHER REPORTED THAT THE PHYSICIAN HAD USED THIS REFILL KIT, RECALLED PRODUCT, BUT DID NOT HAVE ANY TROUBLE WITH NORMAL PROTOCOL REFILL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298775 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR