BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPORARY BIPOLAR MYOCARDIAL PACING LEAD

    MDR report key: 1881043 · Received October 18, 2010

    Report

    Report Number
    6000029-2010-00004
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LDF
    PMA / PMN Number
    K963898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: THE PRODUCT WAS RETURNED AND CONTINUES TO UNDERGO ANALYSIS. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. FOLLOWING ANALYSIS, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING A HEART VALVE IMPLANT, DURING THE POST-OP PERIOD, THE PATIENT HAD A CARDIAC ARREST AND THIS TEMPORARY PACING WIRE DID NOT STIMULATE THE HEART DUE TO A FRACTURE. IT IS UNKNOWN IF THE FRACTURE OCCURRED PRIOR TO OR DURING THE CARDIAC ARREST.

    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 Life Threatening