BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2143057 · Received June 23, 2011

    Report

    Report Number
    6000030-2011-04703
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 26, 2011
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) .

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2011 THAT A PT HAD CHANGE IN THERAPEUTIC EFFECT AND WAS EXPERIENCING INTERMITTENT LETHARGIC PERIODS AND EXCESSIVE SLEEPINESS THROUGHOUT THE DAY. THE DRUG DOSE WAS LOWERED. THE PUMP WAS REPORTED TO CONTAIN PF MORPHINE WITH 1% BUPIVICAINE AT A CONC OF 25 MG/ML AND A DOSE OF 5 MG/DAY. THE PUMP AND ORAL MEDICATION WERE BOTH REPORTED AS CAUSING THE EVENT. IT WAS UNK WHETHER A PRODUCT PROBLEM OCCURRED. THERE WAS NO PROBLEM REPORTED WITH THE PROGRAMMING. THERE WAS NO SURGICAL INTERVENTION AT THE TIME OF REPORT, BUT AN APPOINTMENT WITH THE SURGEON WAS PLANNED FOR A "POSSIBLE PUMP UPDATE". THE PT WAS HOSPITALIZED AND THE OUTCOME WAS REPORTED AS NON-SERIOUS ILLNESS/INJURY. ADD'L INFO WILL BE REPORTED IF IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization EXPLANTED:| CATHETER: MODEL 8709, LOT# J12262R30| IMPLANTED: