BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4152991 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18559
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THERE WAS A MIX-UP WITH THE PATIENT¿S REFILL DATE. THE PATIENT MISSED THEIR REFILL, AND NO ONE HEARD THE LOW (LRA) OR EMPTY RESERVOIR ALARMS (ERA). THE CRITICAL AND NON-CRITICAL ALARM TESTS WERE PERFORMED WITH THE 8840 AND THE ALARM SOUNDS COULD NOT BE HEARD. PATIENT SYMPTOMS INCLUDED SLEEPING DIFFICULTY AND TWITCHING OF THEIR EXTREMITIES. THE PATIENT¿S MOTHER REPORTEDLY TOOK THE PATIENT TO THE EMERGENCY ROOM BECAUSE OF THE PATIENT¿S TWITCHING AND DIFFICULTY SLEEPING, AS WELL AS THE REALIZATION THAT THE PUMP NEEDED TO BE REFILLED. IT WAS ALSO NOTED THAT THE PATIENT DEVELOPED AN UPPER RESPIRATORY VIRAL INFECTION AND ENDED UP AT A HOSPITAL, THOUGH THE VIRUS WAS NOT RELATED TO THE PUMP. AT THE HOSPITAL THE PUMP WAS REFILLED WITH LIORESAL. THE PUMP WAS INTERROGATED AND SHOWED THE LRA OCCURRED ON (B)(6) 2014. THE ERA OCCURRED ON (B)(6) 2014. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. THE REPRESENTATIVE NOTED THAT THE PUMP WAS IMPLANTED A BIT DEEPER THAN WHAT THEY HAD TYPICALLY SEEN. THE PUMP HAD CONTAINED BACLOFEN. ADDITIONAL INFORMATION WAS REQUESTED TO DETERMINE THE PATIENT¿S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631984 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR Hospitalization