BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 3231495 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01919
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    May 16, 2013
    Report Date
    July 2, 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, AN ELECTRICAL AND A MECHANICAL INSPECTION. THE VISUAL INSPECTION SHOWED SQUEEZES OF THE LEAD BODY, WHICH OCCURRED MOST LIKELY DURING THE 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 ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, AFTER MULTIPLE ATTEMPTS TO POSITION THIS ATRIAL LEAD, THE LEAD WOULD DISLODGE. FINALLY, A SUITABLE POSITION WAS OBTAINED AND THE POCKET WAS CLOSED. POST PROCEDURE, WHILE TRANSFERRING TO A BED, THIS LEAD DISLODGED. A DECISION WAS MADE TO REPLACE THIS LEAD. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332213 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 360303

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization