BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1994283 · Received January 14, 2011

    Report

    Report Number
    3004209178-2011-00392
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE HCP (HEALTHCARE PROVIDER) WAS ABLE TO ASPIRATE THE RESERVOIR, BUT UNABLE TO FILL IT. THE REFILL KIT TUBING WAS PATENT. THE NEEDLE WAS PATENT. THERE WAS A DEPTH ISSUE. THE PUMP DID NOT MOVE AROUND IN THE POCKET. THE SILICONE RUBBER SEPTUM WAS FELT UPON NEEDLE INSERTION. THE PUMP REFILL WAS ATTEMPTED WITH 2 DIFFERENT REFILL KITS SO THE HCP DID NOT BELIEVE IT WAS A TUBING/NEEDLE ISSUE. IT WAS LATER REPORTED ON (B)(6) 2011 THE PT EXPERIENCED FLU-LIKE SYMPTOMS; THE HCP DID NOT BELIEVE THE SYMPTOMS WERE RELATED TO THE PUMP. THE ISSUE OF BEING ABLE TO ASPIRATE BUT UNABLE TO FILL THE RESERVOIR RE-OCCURRED. THE ACTUAL RESIDUAL VOLUME (15ML) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (9-10 ML). THE HCP WAS EVENTUALLY ABLE TO REFILL THE PUMP. THE PUMP WAS FILLED WITH 30 ML OF FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male CATHETER: MODEL 8709, LOT# J0058184R| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J0058184R| EXPLANTED: