BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 3880312 · Received June 18, 2014

    Report

    Report Number
    1028232-2014-02011
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 6, 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. 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. 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. FURTHER INSPECTION SHOWED DEFORMATIONS OF THE OUTER COIL WHICH WERE CAUSED MOST LIKELY DURING THE EXPLANT PROCEDURE. IN SUMMARY, THE LEAD'S DISTAL PART WAS FOUND PARTLY PULLED OUT OF THE RING ELECTRODE. 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 EXHIBITED PACING INHIBITION AS WELL AS MUSCLE STIMULATION DUE TO DISLODGMENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO CAPTURE WAS ALSO OBSERVED. THE PATIENT IS NOT PACER-DEPENDENT. THE RV LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357068 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization