BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 3231561 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01921
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 24, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION SHOWED DEFORMATIONS OF THE CONDUCTOR COIL AND CUTTINGS IN THE INSULATION WHICH OCCURRED MOST LIKELY DURING SURGERY. IN THE COURSE OF THE FURTHER ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE LEAD PROVED TO BE WITHIN SPECIFICATIONS AND FLAWLESS THROUGHOUT ITS INSPECTION. 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 VENTRICULAR LEAD HAS HAD A HISTORY OF OVERSENSING AND NOISE ISSUES. THE LEAD WAS ALSO CAUSING THE PATIENT CHEST PAIN AND THE PHYSICIAN WAS WONDERING IF THE LEAD POSITION MIGHT HAVE CONTRIBUTED TO A PULMONARY EMBOLISM SIX MONTHS PRIOR. THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH ANOTHER LEAD. THE EXPLANTED LEAD WILL BE COMING BACK FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331589 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization