BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3981221 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13969
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(6), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A STAPH INFECTION 5-6 WEEKS AFTER IMPLANT. THE PATIENT STATED THAT SHE WAS TOLD THAT IT WAS FROM ¿WHEN THEY STUCK A TUBE DOWN HER NOSE INTO HER THROAT¿ AND ¿IT ATTACKED THE DEVICE.¿ ¿IT WASN¿T FROM HAVING THE SURGERY TO PUT IN THE NEW PUMP.¿ THE PUMP WAS DELIVERING MORPHINE AT THE TIME OF THE EVENT. THE PATIENT HAD WITHDRAWAL AFTER THEY TOOK THE PUMP OUT WHILE SHE WAS WAITING TO HAVE A NEW PUMP PUT IN. THEY HAD TO ¿BRING UP THE ORAL MEDS TO EQUAL WHAT WAS IN THE PUMP.¿ THE PATIENT ¿GOT THE SHAKES.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458145 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention