BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2482700 · Received March 7, 2012

    Report

    Report Number
    3004209178-2012-01422
    Event Type
    Injury
    Date Received
    March 7, 2012
    Report Date
    February 14, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER MODEL#8709SC SERIAL#(B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: UNK; DACRON POUCH MODEL#8590-1 LOT#N162345 IMPLANTED: (B)(6) 2009 EXPLANTED: UNK.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PER PATIENT, THEY EXPERIENCED A PUMP INFECTION FOR FOUR YEARS. THERE WERE NO SIGNS/SYMPTOMS NOTED AT TIME OF EXPLANT. THE PRIMARY LOCATION OF THE INFECTION WAS UNKNOWN. NO CULTURE WAS OBTAINED; TREATMENT WAS UNKNOWN. IT WAS INDICATED THAT THE PUMP ORIGINALLY HAD MORPHINE; CHANGED TO NORMAL SALINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REMOVED BECAUSE OF INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention