BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPORARY BIPOLAR MYOCARDIAL PACING LEAD

    MDR report key: 1921816 · Received December 6, 2010

    Report

    Report Number
    2025587-2010-00153
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 17, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LDF
    PMA / PMN Number
    K963898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: METHOD: DEVICE HISTORY COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED. RESULTS: NO PRODUCT WAS RETURNED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT FOLLOWING THE PLACEMENT OF THIS TEMPORARY PACING WIRE, WHEN THE SURGEON PULLED THE LEAD OFF THE HEART TO REPOSITION IT, THE WIRE PART BROKE OFF. THE LEAD SECTION WAS SALVAGED, BUT THE WIRE REMAINED IN THE PT. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPORARY BIPOLAR MYOCARDIAL PACING LEAD LDF MEDTRONIC HEART VALVES, INC. 6495 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other