BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 3242679 · Received July 23, 2013

    Report

    Report Number
    1028232-2013-01962
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    May 31, 2013
    Report Date
    July 10, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. WITH REGARD TO THE ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. VISUAL INSPECTION DEMONSTRATED THAT THE LEAD'S DISTAL PART WAS FOUND BENT AND PARTLY PULLED OUT FROM THE RING ELECTRODE. BASED ON THE CHARACTERISTICS OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES. THE CUTTING IN THE INSULATION AND A DEFORMATION OF THE COIL IN THE PROXIMAL PART RESULTED MOST LIKELY FROM THE SURGERY. 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 HAD FRACTURED AND WAS OVERSENSING. THE LEAD WAS EXPLANTED AND A REPLACEMENT RA LEAD WAS IMPLANTED IN ITS PLACE. NO ADVERSE PATIENT EFFECTS WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342736 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization