BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 1893608 · Received November 1, 2010

    Report

    Report Number
    1028232-2010-02303
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    August 19, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISLODGED ONCE DURING THE IMPLANT PROCEDURE. THE LEAD WAS REPOSITIONED AND THE PACEMAKER POCKET WAS CLOSED. THE RV LEAD WAS RETESTED PRIOR TO LEAVING THE SURGICAL ROOM; THE TEST REVEALED THAT THE LEAD WAS NOT SENSING OR CAPTURING. AT THIS POINT THE PATIENT STARTED TO EXPERIENCE CHEST PAIN, SO THE PROCEDURE WAS ENDED IN ORDER TO ALLOW THE PATIENT TO RECOVER. A CHEST X-RAY SHOWED THAT THE LEAD HAD DISLODGED. FOUR DAYS LATER THE PATIENT'S ENTIRE SYSTEM WAS EXPLANTED FOR A BI-VENTRICULAR DEVICE UPGRADE. IT WAS NOTED THAT THE PATIENT HAD A LOW EJECTION FRACTION AND AN INTRINSIC HEART RATE OF 135 BPM PRIOR TO THE ORIGINAL DEVICE IMPLANTATION. UPON EXPLANT, THE ENTIRE PACEMAKER SYSTEM WAS SENT TO THE HOSPITAL'S PATHOLOGY DEPARTMENT, AS PER HOSPITAL PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION RELATED TO THIS EVENT IS AVAILABLE TO THE COMPANY AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization