BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 3053644 · Received April 11, 2013

    Report

    Report Number
    1028232-2013-00936
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 28, 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 WAS FOUND DISSECTED AT APPROXIMATELY 7 CM DISTAL TO THE IS-1 CONNECTOR PIN. THE FRAGMENTATION OF THE LEAD MOST LIKELY ORIGINATED FROM THE EXPLANTATION PROCEDURE. VISUAL INSPECTION DEMONSTRATED CUTTINGS IN THE INSULATION AND A DEFORMATION OF THE OUTER COIL WHICH RESULTED MOST LIKELY FROM THE EXPLANTATION PROCEDURE. MOREOVER, THE LEAD'S DISTAL PART WAS FOUND PARTLY PULLED OUT FROM THE RING ELECTRODE. TRACTION FORCES DURING THE SURGERY SHOULD BE TAKEN INTO CONSIDERATION. DURING FURTHER ANALYSIS, NO FURTHER DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD PERFORATED THE TRICUSPID VALVE WHEN IT WAS BEING IMPLANTED IN THE PATIENT'S ATRIUM. THE LEAD WAS ABANDONED TO PREVENT FURTHER DAMAGE. THE PATIENT REMAINED STABLE. THE IMPLANT DATE WAS NOT PROVIDED, HOWEVER, THE REPORT STATED THAT THE LEAD WAS ABANDONED IN THE PATIENT FOR APPROXIMATELY 42 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156822 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization