BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1930296 · Received November 24, 2010

    Report

    Report Number
    6000030-2010-09917
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 11, 2010
    Manufacturer
    RICKE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AT THE PUMP REFILL, AN ABNORMAL INFUSION RATE WAS OBSERVED. THE EXPECTED RESIDUAL VOLUME (3.3ML) WAS LESS THAN THE ACTUAL VOLUME (11.2ML). ON (B)(5) 2010, A CATHETER DYE TEST AND A ROTOR STUDY WERE DONE; THE RESULTS CAME BACK AS NO ANOMALY. SINCE THE PATIENT DID NOT EXPERIENCE ANY RETURN OF SYMPTOMS, THE DOCTOR DECIDED TO OBSERVE UNTIL THE NEXT REFILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICKE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention IMPLANTED:| CATHETER: MODEL 8711, LOT# N073163010| EXPLANTED: