BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1020539 · Received March 28, 2008

    Report

    Report Number
    1028232-2008-00325
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    January 25, 2008
    Report Date
    March 3, 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 MECHANICAL PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. PARTICULARLY WITH REGARD TO THE LEAD DISLODGEMENT AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE INVESTIGATIONS DID NOT SHOW ANY DEVIATIONS FROM THE MECHANICAL SPECS. THE FIXATION HELIX COULD BE FULLY EXTENDED AND RETRACTED. HOWEVER, DUE TO COAGULATED BLOOD AND TISSUE RESIDUALS, THE MEASUREMENT RESULTS DEMONSTRATED DEVIATIONS WITH RESPECT TO NUMBER OF TURNS REQUIRED TO EXTEND THE HELIX. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MFG PROBLEM.

    Description of Event or Problem · 1

    THE CRM RECEIVED INFO THAT THIS RA PACING LEAD HAD DISLODGED. THE LEAD COULD NOT BE REPOSITIONED DUE TO TISSUE LODGED IN THE HELIX MECHANISM. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. TO DATE, THERE HAVE BEEN NO REPORTED PT SYMPTOMS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    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 Hospitalization