BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2974059 · Received February 13, 2013

    Report

    Report Number
    1028232-2013-00216
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 28, 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

    UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION SHOWED CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE CONDUCTOR COIL WHICH OCCURRED MOST LIKELY DURING SURGERY. DURING FURTHER ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE LEAD PROVED TO BE WITHIN SPECIFICATIONS AND FLAWLESS THROUGHOUT ITS INSPECTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS IMPLANTED AS PART OF A SYSTEM REVISION. A CHANGE IN THE LEAD MEASUREMENTS WERE OBSERVED A DAY AFTER THE PROCEDURE AND INVESTIGATIONS WERE MADE TO CONFIRM THE REASONS BEHIND THE NOTED LOSS OF CAPTURE, A SUDDEN INCREASE IN THRESHOLD MEASUREMENTS AND A DROP IN THE R-WAVES. THE PHYSICIAN DECIDED TO EXPLANT THE DISLODGED RV LEAD AND A REPLACEMENT LEAD WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64081 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization