BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2297571 · Received October 11, 2011

    Report

    Report Number
    3004209178-2011-08729
    Event Type
    Injury
    Date Received
    October 11, 2011
    Date of Event
    December 18, 2010
    Report Date
    October 5, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT EXPERIENCED INCREASED PAIN DUE TO FLIPPED PUMP. WHEN EXAMINED ON (B)(6) 2010 THE PUMP COULD NOT BE REFILLED. DRUG DELIVERED WAS MORPHINE 10.0 MG/ML AT A DAILY DOSE OF 2,567 MG. A FLUORO SHOWED THE PUMP UPSIDE DOWN. A SURGICAL REPOSITIONING; PUMP FLIPPED BACK TO RIGHT SIDE UP AND DOWN ON (B)(6) 2010. PT OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N262607005