BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 3112474 · Received May 14, 2013

    Report

    Report Number
    3007566237-2013-01615
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    A REPRESENTATIVE REPORTED THAT IN A PROCEDURE HE DID, THE PUMP SAID ¿SHELF STATE, BUT THERE WAS NO PENDING ALARM¿. THIS WAS NOTED TO HAVE OCCURRED ABOUT FOUR OR FIVE MONTHS PRIOR TO THE REPORT. THE PHYSICIAN READ THE LOGS AND FOUND A MESSAGE INDICATING A MOTOR STALL AND MOTOR STALL RECOVERY OCCURRED. IT WAS UNCLEAR IF AND WHEN THE PUMP WAS IMPLANTED. THE REPRESENTATIVE FURTHER STATED THAT WHEN HE INITIALLY INTERROGATED THE PUMP, NOTHING CAME UP; THAT THERE WAS NO WARNING AND IT HAPPENED AFTER THE INITIAL PRINTOUT; THAT THERE WAS NO WARNING OR ANYTHING ON THE 8840. THE REPRESENTATIVE STATED THAT ¿IN ALL LIKELIHOOD HE COULD HAVE MISSED IT¿. NO PATIENT SYMPTOMS WERE REPORTED, AND NO PATIENT OUTCOME WAS PROVIDED. THE MEDICATION USED WITHIN THE SYSTEM WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212735 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1