BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3200135 · Received July 1, 2013

    Report

    Report Number
    3007566237-2012-02191
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    November 26, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO CORRECT CONCLUSION CODES.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESIDUAL PUMP VOLUMES WERE GREATER THAN EXPECTED, AND SOMETIMES THE DISCREPANCY WAS GREATER THAN 25%. ON (B)(6) 2008, THE ACTUAL RESIDUAL VOLUME WAS 7.4 CC¿S AND THE EXPECTED RESIDUAL WAS 11 CC. THE PATIENT WAS EXPERIENCING INTERMITTENT NAUSEA OVER THE LAST COUPLE OF MONTHS, AND INCREASED PAIN; HIS ¿LEGS HURT MORE OFF AND ON¿. THE PATIENT WAS TAKING HIGHER DOSES OF HIS ORAL PAIN MEDICATION, AND WAS RECEIVING MORPHINE AND SUFENTA THROUGH THE PUMP. THE PUMP LOGS WERE CHECKED AND NO MOTOR STALLS WERE NOTED. A CATHETER STUDY WAS DONE (B)(6) 2008 AND NO ABNORMALITIES WERE DETECTED; CSF WAS ASPIRATED EASILY AND THE DYE FLOWED FREELY. AT THE NEXT REFILL ON (B)(6) 2008, RESIDUALS WERE REPORTED TO BE ¿OK¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299367 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1