BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2954986 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02504
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 14, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8835, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE SEVERAL MOTOR STALLS AND PERSONAL THERAPY MANAGER (PTM) LOCK OUTS. THE MULTIPLE MOTOR STALLS WERE ALL SHORT IN DURATION, (5 TO 15 MINUTES EACH) AND HAPPENING APPROXIMATELY THE SAME TIME OF THE DAY. THE REPORTER STATED IT APPEARED TO LOOK LIKE POSSIBLE EMI INTERFERENCE, AND IT WAS NOTED THE PATIENT MAY BE USING A MAGNETIC BRACELET FOR AN UNRELATED MEDICAL ISSUE. THE PTM LOCK OUT ATTEMPTS WERE THOUGHT BY THE REPORTER TO BE EITHER ACTUAL LOCK OUT ATTEMPTS IN WHICH THE PATIENT REQUESTED A BOLUS DURING A LOCK OUT PERIOD, OR A FAILED TELEMETRY WITH THE PTM THAT SHOWED UP AS A LOCK OUT ATTEMPT, WHEN IT GOT BACK TO THE PTM REPORT. THE PATIENT COULD HAVE REMOVED THE PTM BEFORE IT WAS FINISHED OR THERE WAS POSSIBLY SOME OUTSIDE INFLUENCE WHICH INTERRUPTED IT. DUE TO THE MANY MOTOR STALLS AND RECOVERIES, IT WAS THOUGHT BY THE REPORTER THAT THE PTM AND PUMP ISSUES WERE DUE TO OUTSIDE INFLUENCES OR AN EMI SOURCE. THE PUMP LOGS REPORTED SHOWED ALL MOTOR STALLS HAD RECOVERED. IT WAS DECIDED THAT THE PUMP WOULD NOT BE EXPLANTED SINCE THE STALLS ARE OF SHORT DURATION AND OF NO INFLUENCE ON THE THERAPY. THE PATIENT WAS TO BE MONITORED CLOSELY. THE DRUG BEING USED IN THE PUMP WAS COMPOUNDED BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE BACLOFEN PUMP INITIALLY WORKED VERY WELL. HOWEVER, FOR ABOUT TWO YEARS PRIOR TO THIS REPORT, THE PUMP GAVE CONTINUOUS PROBLEMS, INCLUDING A CRITICAL ALARM. IN (B)(6), THE PUMP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59845 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention