BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2112358 · Received May 27, 2011

    Report

    Report Number
    1028232-2011-01190
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    April 5, 2011
    Report Date
    May 24, 2011
    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 RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD DEVELOPED A HIGH THRESHOLD MEASUREMENT OF 2.8 VOLTS AND INTERMITTENT LOSS OF CAPTURE POST IMPLANT. A LEAD REVISION PROCEDURE WAS SCHEDULED FOR THE FOLLOWING DAY. IT WAS NOTED THAT THE RV LEAD HAD PERFORATED AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR AN EMERGENCY PERICARDIAL WINDOW DUE TO A LARGE PERICARDIAL EFFUSION. THE BLOOD WAS REMOVED FROM THE PERICARDIAL SAC AND AN ATTEMPT TO REPOSITION THE LEAD WAS UNSUCCESSFUL. THE RV LEAD WAS TAKEN OUT OF THE POCKET AND VISUAL INSPECTION NOTED AN ISSUE WITH THE HELIX MECHANISM. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THAT THE INTERMITTENT LOSS OF CAPTURE AND HELIX ISSUE WERE LIKELY DUE TO OVER TURNING OF THE MECHANISM BY THE PHYSICIAN WHEN ATTEMPTING TO REPOSITION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION 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