BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1812486 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-06153
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 18, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ABDOMINAL INFECTION IN THE PUMP POCKET. A CULTURE OF THE SITE INDICATED A (B)(6) INFECTION. THE DRUG IN THE PUMP WAS LIORESAL 2000 MCG AT 250 DOSE PER DAY. THE PUMP WAS NOT EXPLANTED. THE SITE WAS "CLEANED OUT." IT WAS STATED THAT THE PATIENT WAS "OK." IT WAS FURTHER REPORTED THAT THERE WAS NO DATA POTENTIALLY OR DIRECTLY ASSOCIATED WITH THE EVENT, CONTAINED IN THE DESIGN HISTORY RECORD (DHR). IT WAS NOTED THAT ALL PARAMETERS COMPLIED WITH THE STERILIZATION PROCESS. THEREFORE, STERILITY OF THE DEVICE WAS MET. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WAS PROVIDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11024R08