BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1213297 · Received October 27, 2008

    Report

    Report Number
    2182207-2008-06912
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP WAS EMPTY SINCE SHE WAS ONE MONTH PAST HER REFILL DATE. THE PATIENT'S PARENTS DID NOT NOTE ANY INCREASED SYMPTOMS OR ALARMS. THE PHYSICIAN'S OFFICE CONTACTED THE PARENTS AND REQUESTED THE PATIENT BE BROUGHT IN FOR REFILL. THE PATIENT WAS ADMITTED TO THE ICU FOR REFILL AND STARTED ON A VERSED DRIP. THE NURSE HAD DIFFICULTY ASPIRATING AND FILLING THE RESERVOIR DURING THE REFILL. IT WAS NOTED THAT THE NEEDLE WAS UNDER THE SKIN AND CAME OUT OF THE REFILL PORT DURING THE REFILL, IT WAS DETERMINED THAT A PARTIAL POCKET FILL HAD OCCURRED. THE PATIENT EXPERIENCED ONLY SLIGHT SLEEPINESS FOR ABOUT FOUR HOURS FOLLOWING THE POCKET FILL. NO INTERVENTIONS WERE NEEDED. THE PHYSICIAN PERFORMED A PUMP REFILL THREE DAYS LATER WITHOUT DIFFICULTY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND DOING FINE. A FOLLOW-UP CALL FROM THE PATIENT'S MOTHER A WEEK LATER NOTED THAT PATIENT WAS STILL DOING FINE. THE PATIENT'S PUMP CONTAINED COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R CATHETER: MODEL 8709| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840| EXPLANTED: