BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2884591 · Received December 23, 2012

    Report

    Report Number
    3004209178-2012-12200
    Event Type
    Malfunction
    Date Received
    December 23, 2012
    Report Date
    November 24, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD A PUMP ALARM. THE PUMP HAD ALARMED BEFORE IN "THE PAST," AND THE PATIENT'S PHYSICIAN WAS NOTIFIED OF THE ALARM. THE PATIENT STATED THAT A MEDICAL DOCTOR AT THE ER HAD THOUGHT HER "PUMP WAS NOT WORKING." THE PATIENT STATED THAT SHE WAS TOLD THE "CATHETER WAS BROKEN" AND THAT ''THE MEDICATION WAS DRAINING INTO HER MUSCLES'' AND ''NOT THE SPINAL CORD.'' TWO DYE STUDIES WERE PERFORMED, THOUGH IT WAS NOT CLEAR IF THEY HAD CONFIRMED THE BROKEN CATHETER. THE PATIENT STATED THAT THERE WERE NO VOLUME DISCREPANCIES, AND NO FALLS OR TRAUMA WAS KNOWN TO BE RELATED TO THE EVENT. THE PATIENT EXPERIENCED A RETURN IN SPASTICITY. THE PATIENT WAS ON HER FULL DOSE OF ORAL BACLOFEN. THE DRUG USED WITHIN THE SYSTEM WAS BACLOFEN (UNKNOWN). NO ADDITIONAL INFORMATION WAS REPORTED.

    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