BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4081807 · Received September 11, 2014

    Report

    Report Number
    3004209178-2014-16835
    Event Type
    Injury
    Date Received
    September 11, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN (B)(6) 2014, THE PATIENT WAS HAVING PAIN; SHE COULD NOT STAND HER PAIN. THEY WERE USING ULTRASOUND TO REFILL HER PUMP AND THE PATIENT FELT THAT HER CURRENT PHYSICIAN WAS NOT TAKING THE TIME TO FIND THE RIGHT MEDICATION FOR HER. AT ONE POINT, THE PHYSICIAN STATED THAT THEY COULD NOT HELP HER AND THEY WANTED TO REMOVE THE PUMP. THE PATIENT WAS LOOKING FOR ANOTHER PHYSICIAN. THE PATIENT STATED THAT SHE HAD HEARD THAT ¿U WERE NOT TO HAVE OBE BY IT? I WILL BE GETTING MY SECOND OBE IN. I HOPE IT WORKS.¿ AS OF (B)(6) 2014, THE PATIENT WAS STILL HAVING CONCERNS WITH HER DEVICE, BUT HAD NOT SOUGHT FURTHER HELP; THE PUMP ALWAYS EITHER HURT OR BURNED. SHE HAD BROUGHT THIS UP MANY TIMES AND HAD NOT GOTTEN ANY ANSWERS. THE PUMP WAS REPLACED. THE PATIENT REQUESTED THAT THE NEW PUMP BE MOVED TO A DIFFERENT LOCATION AS SHE WASN¿T COMFORTABLE WITH THE PUMP WERE IT WAS AT. THE MEDICATION IN THE PUMP AT THE TIME OF THE EVENT AND ADDITIONAL DETAILS REGARDING THE EVENT WERE NOT REPORTED. FURTHER FOLLOW-UP HAS BEEN CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560958 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention