BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3122874 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-08009
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4) (AUTONOMIC DYSREFLEXIA). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS A C7 QUADRIPLEGIC AND PRESENTED YESTERDAY EVENING OR THIS MORNING WITH INCREASED SPASMS, BLOOD PRESSURE 190/90, AND A TEMPERATURE OF 101 THAT WAS THOUGHT TO BE ¿ASEPTIC¿ IN ORIGIN. THE PATIENT WAS SENT TO THE ER AND WAS ADMITTED TO THE HOSPITAL. A FLOW STUDY WAS SCHEDULED FOR (B)(6) 2013. THE PATIENT'S STATUS WAS REPORTED TO BE ¿ALIVE - WITH INJURY.¿ THE PUMP WAS DELIVERING BACLOFEN. IT WAS LATER REPORTED THAT THE FLOW/ROTOR STUDY WAS COMPLETED ON THE PATIENT. THREE CC OF CSF WAS ASPIRATED THROUGH CATHETER ACCESS PORT. DYE WAS INJECTED AND VISUALIZED EXITING THE CATHETER TIP IN THE INTRATHECAL SAC. THE ROTOR STUDY SHOWED 60 DEGREE ROTATION. NO EXTRA VISUALIZATION OF DYE NOTED ALONG CATHETER TRACK OR AT CONNECTION POINTS. IT WAS LATER REPORTED THAT THE PUMP WAS DELIVERING LIORESAL. IT WAS LATER REPORTED THAT APPROXIMATELY 1 WEEK AFTER THE CURRENT PUMP WAS IMPLANTED (THE PRIOR PUMP WAS REMOVED DUE TO BATTERY DEPLETION), THE PATIENT DEVELOPED NEUROLOGICAL AUTONOMIC DYSREFLEXIA. THE PATIENT ALSO HAD AN ELEVATED TEMPERATURE OF APPROXIMATELY 101-102 AND A FEVER. NO INFECTION SOURCE WAS EVER FOUND; THE PATIENT HAD NO ELEVATED WBC. THE BACLOFEN FLOW STUDY WAS DONE AND FOUND THE PUMP TUBING WAS ALL ¿OKAY.¿ THE PATIENT WAS HOSPITALIZED FOR APPROXIMATELY 2-3 DAYS. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS DELIVERING GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224550 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Hospitalization