BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2032362 · Received March 28, 2011

    Report

    Report Number
    6000030-2011-02334
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    October 5, 2010
    Report Date
    March 11, 2011
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FINAL DEVICE ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND - NORMAL DEVICE FUNCTION.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED A WOUND DEHISCENCE AND INFECTION. THE DEVICE WAS EXPLANTED DUE TO THE INFECTION. THE INFECTION NEEDED TO BE TREATED; THE TREATMENT WAS UNSPECIFIED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709, LOT# J11637R58| EXPLANTED: