BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1211770 · Received October 24, 2008

    Report

    Report Number
    1028232-2008-01287
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    August 13, 2008
    Report Date
    September 26, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.,
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE SPECIFICATIONS THAT CAN BE RELATED TO THE ISSUES MENTIONED IN THE COMPLAINT DESCRIPTION. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM. THE LEAD WAS FOUND DISSECTED. DUE TO THESE DAMAGES, THE MECHANICAL TEST OF THE LEAD WAS NOT FEASIBLE. IT IS REASONABLE TO ASSUME THAT THE DISSECTION OF THE LEAD WAS DUE TO THE EXPLANTATION PROCEDURE. THE ELECTRICAL ANALYSIS OF THE RETURNED LEAD FRAGMENT DID NOT SHOW ANY DEVIATIONS FROM THE ELECTRICAL SPECIFICATIONS THAT CAN BE RELATED TO THE ISSUES MENTIONED IN THE COMPLAINT DESCRIPTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT APPROXIMATELY TWO MONTHS POST-IMPLANT, THIS LEAD DISLODGED. DURING A LEAD REVISION PROCEDURE, THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK GMBH AND CO., 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization