BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 6617369 · Received June 7, 2017

    Report

    Report Number
    3007566237-2017-02211
    Event Type
    Malfunction
    Date Received
    June 7, 2017
    Report Date
    June 7, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN (UNKNOWN DOSE AND CONCENTRATION) VIA AN IMPLANTABLE PUMP. DURING THE PATIENTS LAST 2 REFILLS (UNKNOWN DATES) THE HEALTH CARE PROFESSIONAL HAD BEEN ASPIRATING CLOUDY DRUG FROM THE RESERVOIR INSTEAD OF IT BEING CLEAR. THE DRUG WAS NOT OLDER THAN 6M AND PATIENT DID NOT HAVE ANY SIDE EFFECTS/SYMPTOMS. THEY WERE NOT CERTAIN IF THERE WAS SOMETHING OUTSIDE OF THE RESERVOIR THAT COULD BE CAUSING THIS. THE COMPANY REPRESENTATIVE HAD REVIEWED CONSIDERATIONS TO RINSE THE PUMP AT THE NEXT REFILL AND FILL WITH THE DRUG AND ASPIRATE AGAIN TO CHECK AND SEE IF IT IS CLEAR. NO FURTHER COMPLICATIONS WERE ANTICIPATED/REPORTED ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE INDICATED THAT THE COMPANY REPRESENTATIVE WAS CONTACTED VIA EMAIL BY THE NURSE. THE PATIENTS NAME AND PUMP SERIAL NUMBER WAS UNKNOWN. NO FURTHER TROUBLESHOOTING WAS DONE TO RESOLVE THE ISSUE. THE COMPANY REPRESENTATIVE INSTRUCTED THE ACCOUNT TO PERFORM A RESERVOIR RINSE, PROPER REFILL TECHNIQUE PUSH THEN PULL DRUG TO SEE IF IT STAYS CLEAR. THE CAUSE OF THE ISSUE AND WHETHER IT HAD BEEN RESOLVED WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400904 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1