BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4135

    MDR report key: 1894626 · Received November 4, 2010

    Report

    Report Number
    1028232-2010-02290
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    August 25, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. WITH REGARD TO THE ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. THE CUTTINGS IN THE INSULATION OCCURRED MOST LIKELY DURING THE SURGERY. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MFG PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM REC'D INFO THAT THIS PT WITH A HISTORY OF SUDDEN BRADY RESPONSE (SBR), HAS FALLEN AND SINCE THEN HAS BEEN FEELING LIGHT-HEADED AND HAVING MORE TROUBLE MANAGING HER SYNCOPE. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE WITH POCKET MANIPULATION AND THE NURSE NOTED CAPTURE ISSUES UPON LEAD ASSESSMENT. A LEAD FRACTURE WAS SUSPECTED. ALTHOUGH THIS LEAD WAS EXPLANTED AND RETURNED, AN EXPLANT DATE WAS NOT PROVIDED. TO DATE, NO FURTHER ADVERSE PT EFFECTS WERE REPORTED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization