BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2962139 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02657
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 16, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PREVIOUSLY REPORTED DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PATIENT PROGRAMMER MODEL: 8835, SERIAL# (B)(4); CATHETER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "PUMP REFILL RESIDUAL VOLUME EXPECTED WAS MUCH HIGHER". THE CAUSE OF THE EVENT IS UNKNOWN. A DYE STUDY ON (B)(6) 2013 SHOWED EXCELLENT SUBARACHNOID SPREAD AND PUMP ROTOR STUDY SHOWED EXCELLENT MOVEMENT OF ROTORS. THE CATHETER WAS EASILY ASPIRATED AND THE INFUSION DYE SHOWED GOOD INTRATHECAL PLACEMENT. THE PATIENT CONTINUED TO HAVE ONGOING PAIN COMPLAINTS DESPITE "INCREASES". AT NEXT PUMP REFILL, IF HIGH RESERVOIR VOLUME RE-ENCOUNTERED WITH A REVISION/REPLACEMENT OF CATHETER WILL BE DONE. THE DRUGS BEING DELIVERED VIA THE PUMP WERE FENTANYL AND BUPIVICAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65427 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1