BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203579 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-04798
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    August 22, 2012
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8835 LOT# SERIAL# UNK, PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 8731SC LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL. FOLLOWING THE FALL, THE PATIENT WAS HOSPITALIZED FOR A WEEK, AND AT THE TIME OF THE REPORT WAS IN A REHAB CENTER. SINCE THE PATIENT FELL, THE PERSONAL THERAPY MANAGER (PTM) WAS HAVING DIFFICULTY COMMUNICATING WITH THE PUMP. THEY WERE GETTING THE "COMMUNICATION UNSUCCESSFUL" SCREEN. IT WAS TAKING ABOUT 10 ATTEMPTS TO COMMUNICATE AND GET THE BOLUS. IT WAS NOTED THAT PATIENT USED THE PTM ONLY WHEN NEEDED, WHICH WASN'T VERY FREQUENT. THERE WAS CONCERN THAT THE PUMP MAY HAVE TURNED OR FLIPPED DUE TO THE FALL, AND WONDERED IF THIS COULD BE CONTRIBUTING TO THE COMMUNICATION ISSUES. THE PUMP CONTAINED A MIXTURE OF MORPHINE AND CLONIDINE. ABOUT 1 ½ MONTHS LATER IT WAS REPORTED THAT THE PUMP WAS REFILLED (B)(6) 2012. FOLLOWING THE REFILL WHEN THE PATIENT FIRST ATTEMPTED TO USE THE PTM AN 8503 BOLUS IN PROGRESS WAS NOTED. IT WAS ALSO NOTED THAT THE REFILL DATE HADN¿T CHANGED. THE PATIENT WAS DIRECTED TO THE PHYSICIAN TO DECOUPLE AND RECOUPLE THE PTM TO CORRECT THE REFILL DATE ON THE PTM. IT WAS NOTED THAT AS OF THE DATE OF THE ADDITIONAL INFORMATION BACLOFEN HAD BEEN ADDED TO THE PUMP. CONTINUED ISSUES WITH COUPLING WERE ALSO STILL NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306292 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization