BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 3053642 · Received April 11, 2013

    Report

    Report Number
    1028232-2013-00929
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 20, 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 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 CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE CONDUCTOR COIL 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 ONE DAY POST IMPLANT THIS RIGHT ATRIAL LEAD EXHIBITED UNDERSENSING. IT WAS DETERMINED THE LEAD WAS DISLODGED. SURGICAL INTERVENTION WAS PERFORMED AND THIS LEAD WAS EXPLANTED AND REPLACED. IT WAS REPORTED THE PATIENT WAS DOING FINE WITH NO ADVERSE PATIENT EFFECTS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154467 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization