BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2023113 · Received February 24, 2011

    Report

    Report Number
    3004209178-2011-01406
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    September 1, 2010
    Report Date
    February 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED "FEELING SICK" WITH DIARRHEA, FLU AND CHILLS AFTER HER VISIT TO THE (B)(6) AT THE END OF (B)(6) 2010. THE PATIENT SUBSEQUENTLY EXPERIENCED PAIN TOWARD THE END OF HER REFILL INTERVAL; THEN FELT GROGGY RIGHT AFTER THE REFILLS. THERE WERE NO VOLUME DISCREPANCIES NOTED PRIOR TO THE REFILL ON (B)(6) 2010. VOLUME DISCREPANCIES WERE NOTED ON THREE OCCASIONS; THE ACTUAL RESIDUAL VOLUME (ARV) WAS LESS THAN THE EXPECTED RESIDUAL VOLUME (ERV): (B)(6) 2010 = 5.9 ML (ERV) - 0.8 ML (ARV); (B)(6) 2010 = 12.6 ML (ERV) - 0.4 ML (ARV); (B)(6) 2011 = 13.2 ML (ERV) - 3.2 ML (ARV). NO OTHER ISSUES WERE NOTED IN THE LOGS OF THE PUMP AND PROGRAMMING "ALWAYS LOOKED CORRECT". THE PUMP WAS PREVIOUSLY FILLED WITH SUFENTANIL AND BUPIVACAINE (MARCAINE); THE PUMP WAS REFILLED WITH SALINE ON (B)(6) 2010 AND (B)(6) 2011. THE HCP PLANNED TO REPLACE THE PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N147411019| EXPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N141335| IMPLANTED: