BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 3241160 · Received July 22, 2013

    Report

    Report Number
    1028232-2013-01963
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    May 22, 2013
    Report Date
    July 10, 2013
    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. ITS PERFORMANCE WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION DEMONSTRATED THAT THE LEAD'S DISTAL PART WAS PARTLY PULLED OUT OF THE RING ELECTRODE. THEREFORE, THE ADHESIVE RESIDUALS ON THE JOINING SURFACE OF LEAD TIP AND THE LEAD BODY WERE ANALYSED. IN ADDITION, THE DISTAL PART OF THE LEAD WAS BENT. THE ANALYSIS REVEALED NO INDICATION OF A MATERIAL OR A MANUFACTURING PROBLEM. AS THE ROOT CAUSE OF THE OBSERVED DAMAGE MECHANICAL STRESS DURING THE SURGERY SHOULD BE TAKEN INTO CONSIDERATION. BLOOD PENETRATED THE LEAD DUE TO THE DAMAGE. FURTHERMORE, ABRASION MARKS WERE NOTED ON THE INSULATION SURFACE, WHICH RESULTED PRESUMABLY FROM THE INTERACTION WITH ANOTHER IMPLANTED LEAD. 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 ATRIAL LEAD SHOWED IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS AND WAS FOUND TO BE UNDERSENSING AND DISLODGED. THE LEAD WAS UNABLE TO BE REVISED SO IT WAS EXPLANTED AND REPLACED WITH A NEW RA LEAD DURING A DEVICE CHANGE-OUT PROCEDURE. THE LEAD IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340733 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization