BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 2895996 · Received November 19, 2012

    Report

    Report Number
    1028232-2012-02991
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    September 2, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    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 MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG 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 RECEIVED INFO THAT THE PT PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF LIGHTHEADEDNESS AND FEELING DIZZY; IT WAS NOTED THAT THE PT DID NOT EXPERIENCE SYNCOPE. A DEVICE INTERROGATION DID NOT REVEAL ANY ISSUE. THE FIELD REP STATED THAT TWO HOURS LATER, HE WAS ASKED TO RETURN TO THE HOSPITAL AS A TELEMETRY STRIP SHOWED ASYSTOLE FOR 4 TO 5 SECONDS. ANOTHER DEVICE INTERROGATION WAS PERFORMED WITHOUT ANY SIGNIFICANT FINDINGS. AFTER MONITORING THE PT, THE FIELD REP OBSERVED A 3 TO 4 SECOND PAUSE ALONG WITH RIGHT VENTRICULAR LOSS OF CAPTURE AND OVERSENSING OF NOISE WAS ABLE TO BE RECREATED WITH ISOMETRICS, POCKET MANIPULATION AND ARM MOVEMENTS. A REVISION PROCEDURE WAS PERFORMED WHERE THE RV LEAD WAS SURGICALLY ABANDONED DUE TO LOSS OF CAPTURE AND INSULATION DAMAGE. IT WAS NOTED THAT THE CAUSE OF THE LOSS OF CAPTURE WAS UNABLE TO BE DETERMINED, HOWEVER, NO LEAD TO DEVICE CONNECTION ISSUE WAS SEEN DURING THE REVISION PROCEDURE. A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADD'L ADVERSE PT EFFECTS WERE REPORTED. AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED.

    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