BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTUS 4135

    MDR report key: 4102096 · Received September 19, 2014

    Report

    Report Number
    1028232-2014-003362
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    July 28, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    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 UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. DURING THE VISUAL INSPECTION, CUTTINGS IN THE INSULATION WERE FOUND. IT IS REASONABLE TO ASSUME, THAT THE CUTTINGS RESULTED FROM THE EXPLANTATION PROCEDURE. BLOOD PENETRATED THE LEAD IN THESE AREAS. FURTHER ANALYSIS OF THE LEAD DID NOT REVEAL ANY IRREGULARITY THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED CLINICAL EVENT. IN SUMMARY, THE LEAD PRESENTED CUTTINGS IN THE INSULATION, WHICH RESULTED PRESUMABLY FROM THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD EXHIBITED PACING NOT DELIVERED WHEN REQUIRED AND NON-DETECTION. THIS RA LEAD WAS FOUND DISLODGED. THE RA LEAD WAS EXPLANTED AND WAS SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584588 DEXTUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization