BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3193349 · Received June 27, 2013

    Report

    Report Number
    3007566237-2013-02135
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER NOTED THAT THE HEALTH CARE PROVIDER HAD NO FURTHER CLARIFYING DETAILS PERTAINING TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY HAD REFILL ISSUES. IT WAS REPORTED THAT THEY WERE HAVING REFILL ISSUES I.E. DIFFICULTY REFILLING THE PUMP AND THEY REPLACED THE PUMP BECAUSE OF THE SAME. AT THE TIME THEY HAD PATIENT GO HOME AND THEN THEY CALCULATED IN THE 24 OR 18 HOURS THAT SHE CAME BACK, HOW MUCH SHE WOULD HAVE USED. AND THE NEXT DAY EVERYTHING WENT SMOOTH AND THERE WAS NO PROBLEM. REPORTER DID NOT PROVIDE DEVICE DETAILS/DRUG INFUSED/ PATIENT SYMPTOMS AND OUTCOME RELATED TO THIS INCIDENT HOWEVER INDICATED THAT THE PUMP WAS SUPPOSED TO BE ANALYZED TO SEE IF THERE WAS ANYTHING WRONG WITH THE BILLOW. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292773 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention