BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2930053 · Received January 25, 2013

    Report

    Report Number
    3004209178-2013-00981
    Event Type
    Injury
    Date Received
    January 25, 2013
    Report Date
    January 3, 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 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S CATHETER WAS EXPLANTED BECAUSE OF A KINK DUE TO THE PUMP FLIPPING. IT WAS STATED THAT THE PATIENT WAS A 'TWIDDLER.' INITIALLY, THE PUMP WAS TO BE FILLED WITH 2000MCG/ML OF DRUG, BUT DUE TO AVAILABILITY, THE PATIENT WAS GIVEN 500MCG/ML. AT THE TIME OF REPORT, IT WAS STATED THAT THE PHYSICIAN DID NOT WANT TO PERFORM A BRIDGE BOLUS TO CLEAR THE PUMP TUBING OF THE HIGHER CONCENTRATION OF MEDICATION. IT WAS STATED THAT THIS WOULD RESULTING IN THE PATIENT RECEIVING APPROXIMATELY FOUR TIMES THE DESIRED AMOUNT OF DRUG PER DAY, OVER A TWO OR THREE DAY PERIOD. THE DRUG USED IN THIS SYSTEM WAS BACLOFEN. LATER THAT SAME DAY, IT WAS REPORTED THAT THE PHYSICIAN HAD DECIDED TO DO THE BRIDGE BOLUS. ELEVEN DAYS LATER, IT WAS REPORTED THAT THE PUMP HAD BEEN FLIPPED SO MANY TIMES THAT THE CATHETER HAD BROKEN OFF. THE KINK WAS AT THE PUMP SITE AND THE BREAK WAS AT THE ENTRY POINT TO THE SPINE. IT WAS STATED THAT A NEW PIECE OF CATHETER WAS RUN FROM THE PUMP TO THE BREAK. AT THAT TIME, THERE WAS 'GOOD' CEREBROSPINAL FLUID FLOW. IT WAS REPORTED THAT THE PATIENT WAS DOING 'FINE' TO THE REPORTER'S KNOWLEDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35009 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention