BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2200762 · Received July 27, 2011

    Report

    Report Number
    1028232-2011-01660
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    May 31, 2011
    Report Date
    July 19, 2011
    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

    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. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR. BOSTON SCIENTIFIC REC'D INFO THAT, DURING A ROUTINE F/U, THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED A LOSS OF CAPTURE (LOC). A FLUOROSCOPIC EXAMINATION WAS PERFORMED, AND REVEALED THIS RV LEAD HAD DISLODGED. A REPOSITIONING PROCEDURE WAS ATTEMPTED, BUT ACCEPTABLE VALUES WERE NOT OBTAINED. THE DECISION WAS MADE TO IMPLANT A NEW RV LEAD. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization