BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 3010720 · Received March 19, 2013

    Report

    Report Number
    1028232-2013-00707
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 5, 2013
    Report Date
    March 6, 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, AN ELECTRICAL AND A MECHANICAL INSPECTION. THE VISUAL INSPECTION DEMONSTRATED THAT THE LEAD¿S DISTAL PART WAS PULLED OUT OF THE RING ELECTRODE. THEREFORE, THE ADHESIVE RESIDUALS ON THE JOINING SURFACE OF LEAD TIP AND THE LEAD BODY WERE ANALYSED. THE ANALYSIS REVEALED NO INDICATION OF A MATERIAL OR A MANUFACTURING PROBLEM. AS THE ROOT CAUSE OF THE OBSERVED DAMAGE TRACTION FORCES DURING THE SURGERY SHOULD BE TAKEN INTO CONSIDERATION. THE CUTTINGS OF THE INSULATION AND THE DEFORMATION OF THE OUTER COIL RESULTED MOST LIKELY FROM THE EXPLANT PROCEDURE. BLOOD PENETRATED THE LEAD. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL LEAD HAD HIGH THRESHOLDS (4.5 V AT 1.2 MS). THE PHYSICIAN ELECTED TO REMOVED THE LEAD. IMAGING WAS OBTAINED, AND IT WAS NOTED THAT THE LEAD WAS DISLODGED. IT IS UNCERTAIN HOW LONG THE LEAD HAD BEEN DISLODGED. THE LEAD WAS REMOVED WITHOUT ISSUE. ANOTHER RIGHT ATRIAL LEAD WAS PLACED, INSTEAD. THE PATIENT WAS HOSPITALIZED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113691 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization