BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1963490 · Received December 20, 2010

    Report

    Report Number
    6000030-2010-10599
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A LOW RESERVOIR PUMP ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. IT WAS UNCLEAR IF A PUMP MEMORY ERROR OCCURRED. ALL PROGRAMMING WAS VERIFIED TO BE CORRECT AND THE PUMP WAS UPDATED. THE PUMP HAD "NOT HAD ANYTHING DONE TO IT" SINCE (B)(6) 2009. A ROLLER STUDY AND DYE STUDY WERE PLANNED TO OCCUR (B)(6) 2010 TO EVALUATE DEVICE FUNCTION. THE PUMP DELIVERED PRIALT. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11783R08