BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2974070 · Received February 13, 2013

    Report

    Report Number
    1028232-2013-00222
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    December 2, 2012
    Report Date
    January 29, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. VISUAL INSPECTION DEMONSTRATED A BEND OF THE IS-1 CONNECTOR PIN AS WELL AS A DEFORMATION OF THE FIXATION HELIX. MECHANICAL STRESS DURING SURGERY SHOULD BE TAKEN INTO CONSIDERATION AS THE CAUSE OF THESE DAMAGES. THE INSPECTION SHOWED CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE CONDUCTOR COIL WHICH OCCURRED MOST LIKELY ALSO DURING SURGERY. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    OUS MDR - BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS IMPLANTED, BUT DISLODGED THREE TIMES. THE FOLLOWING DAY, A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS REMOVED AND REPLACED SUCCESSFULLY. THE DEVICE WAS PROGRAMMED TO VDD PACING MODE. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64320 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK SE & CO. KG 360309

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization