BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1932070 · Received November 30, 2010

    Report

    Report Number
    6000030-2010-10033
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CARDIAC CONDITION. (B)(4) CARDIAC CONDITION.

    Description of Event or Problem · 1

    THE PUMP WAS CHECKED (B)(6) 2010 BY THE HCP AND MEDTRONIC REP. IT WAS UNCLEAR PER THE REPORTER WHICH DIAGNOSTICS WERE PERFORMED AT THAT TIME. THE PT WAS SCHEDULED TO HAVE THE PUMP REPLACED (B)(6) 2010. DUE TO THE PT'S CARDIAC CONDITION SURGERY HAD TO BE POSTPONED. THE PUMP WAS EXPECTED TO BE BELOW LOW RESERVOIR VOLUME, HOWEVER, 16.5 ML WAS ASPIRATED. THE PUMP WAS FILLED DESPITE THE VOLUME DISCREPANCY. ADDITIONAL 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 MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT# B002904N37| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731, LOT# B009995N29