BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 4947664 · Received July 28, 2015

    Report

    Report Number
    3007566237-2015-02117
    Event Type
    Death
    Date Received
    July 28, 2015
    Date of Event
    July 6, 2015
    Report Date
    August 21, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF DEATH IS UNKNOWN. IT WAS KNOWN THAT THE PATIENT PASSED AWAY 15 YEARS AGO. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT DID NOT HAVE A MESH THAT SECURES THE PUMP. (NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD FLIP THEIR PUMP. THE PATIENT HAD DEVELOPED A LEAK IN THE PUMP. THE PATIENT PASSED AWAY FROM THE LEAK IN THE PUMP ISSUE. THE PATIENT HAD PASSED AWAY ABOUT 15 YEARS AGO. THE PUMP ALARMED DURING THE PATIENT'S FUNERAL. IT WAS UNKNOWN WHAT THE PUMP SYSTEM WAS DELIVERING. (NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489084 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death