BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 2821126 · Received November 6, 2012

    Report

    Report Number
    3007566237-2012-02629
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 10, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED DURING THE EVENT THE PATIENT WAS BURNING UP AND COLD. THE PATIENT¿S HEADACHES WERE BETWEEN THE TEMPLES. THE DATE OF ONSET OR DIAGNOSIS OF THE INFECTION WAS (B)(6) 2012. SYMPTOMS INCLUDED REDNESS AND SWELLING. AS OF (B)(6) 2012 THE PATIENT NO LONGER HAD MENINGITIS AND THE INFECTION RESOLVED. IT WAS NOTED THE TRIAL WENT POSITIVE, BUT IT GOT INFECTED WITH THE HOSE TO THE ¿POP DOOR.¿ THE CATHETER GOT CAUGHT ON THE EMERGENCY BRAKE ON A CAR AND ¿IT POPPED.¿ FLUID WAS SEEN COMING OUT. THERE WERE FIVE ¿GOOD SIZE COILS¿ TAPED TO THE SIDE OF IT AND THE PATIENT AND HIS DAUGHTER TRIED TO PUT THE CATHETER BACK IN AND COULDN¿T. THE PATIENT¿S HEALTH CARE PROFESSIONAL (HCP) ¿YANKED¿ THE CATHETER OUT IN THE EMERGENCY ROOM. IT WAS ALSO REPORTED THE PATIENT HAS A SCHEDULED APPOINTMENT WITH A NEW HCP TO HAVE A NEW PUMP PUT IN THE END OF (B)(6) 2012.

    Description of Event or Problem · 1

    THE NARRATIVE REPORTED IN MANUFACTURER REPORT # 3007566237-2012-02629 ¿IT WAS ALSO REPORTED THE PATIENT HAS A SCHEDULED APPOINTMENT WITH A NEW HCP TO HAVE A NEW PUMP PUT IN THE END OF (B)(6) 2012.¿ WAS REPORTED IN ERROR AND DID NOT APPLY TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PATIENT'S TRIAL "IT" GOT INFECTED AND THE CATHETER "POPPED" THE SECOND DAY. THE PATIENT WAS HOSPITALIZED AND THE TRIAL WAS TAKEN OUT IN THE EMERGENCY ROOM (ER). ABOUT A WEEK AND A HALF LATER THE PATIENT DEVELOPED A "HUMONGOUS HEADACHE." SINCE THE PUMP TRIAL, THE PATIENT HAS HAD HEADACHE 4 TIMES (THIS INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURER REPORT #3007566237-2012-01685). IT WAS LATER REPORTED THAT THE PATIENT HAD GOTTEN MENINGITIS DURING THE PUMP TRIAL IN 2008. THE TRIAL WAS REPORTED TO HAVE BEEN SUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R