BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 3231573 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01916
    Event Type
    Injury
    Date Received
    July 17, 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, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION DEMONSTRATED A DAMAGED IS-1 CONNECTOR PIN. MECHANICAL FORCES DURING SURGERY SHOULD BE TAKEN INTO CONSIDERATION. DURING FURTHER ANALYSIS, NO OTHER DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN SUMMARY, THE IS-1 CONNECTOR PIN WAS FOUND TO BE DAMAGED. 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 BRADY LEAD HAD DISLODGED. THIS LEAD WAS REPORTEDLY PICKING UP THE VENTRICULAR ACTIVITY AND PACING THE ATRIUM. AN X-RAY CONFIRMED THE ATRIAL LEAD FELL INTO THE VENTRICULAR LEAD. THE PHYSICIAN WAS NOT ABLE TO REPOSITION THE ORIGINAL ATRIAL LEAD SO DECIDED TO EXPLANT THE LEAD. A NEW LEAD WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE EVENT AND EXPLANT DATES PROVIDED DID NOT MAKE SENSE SO THEY WERE LEFT OUT OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331623 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization