BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPORARY BIPOLAR MYOCARDIAL PACING LEAD

    MDR report key: 1000966 · Received February 15, 2008

    Report

    Report Number
    6000029-2008-00001
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 18, 2008
    Report Date
    January 18, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LDF
    PMA / PMN Number
    K963898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. THE PRODUCT HAS BEEN RETURNED FOR ANALYSIS. TO DATE, THE ANALYSIS HAS NOT BEEN COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS TEMPORARY PACING LEAD EXHIBITED PACING INSUFFICIENCY 2 TO 3 DAYS POST IMPLANT. THE DECISION WAS MADE TO REMOVE THE LEAD, WHICH WAS PERFORMED 8 DAYS POST IMPLANT. WHEN THE LEAD WAS REMOVED FROM THE PATIENT, THE DISTAL ELECTRODE WAS FOUND TO HAVE DETACHED FROM THE LEAD, AND REMAINS WITHIN THE PATIENT.

    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 UNK YR Disability