BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 3055881 · Received April 12, 2013

    Report

    Report Number
    3007566237-2013-01254
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Report Date
    March 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

    PRODUCT ID: 8835, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: NEU_UNKNOWN_CATH, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PTM DISPLAYED AN ERROR CODE OF 8478 WHEN ATTEMPTING TO DELIVER A BOLUS. IT WAS REVEALED THAT THE PUMP WAS IN SAFE RATE, WHICH MEANT THAT THE PUMP WAS IN MINIMUM RATE MODE. NO ALARMS WERE HEARD, AND NO PATIENT SYMPTOMS WERE REPORTED. THE PATIENT'S HEALTHCARE PROVIDER WAS NOTIFIED AND THEIR PHYSICIAN PLANNED TO "HANDLE THE SITUATION FROM THERE." NO FURTHER INFORMATION REGARDING THE PATIENT WAS REPORTED. THE MEDICATION USED WITHIN THE SYSTEM WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159058 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1