BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1984485 · Received February 1, 2011

    Report

    Report Number
    1028232-2011-00188
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    December 8, 2010
    Report Date
    January 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 THIS RIGHT ATRIAL (RA) LEAD HAD DISLODGED AFTER THE INITIAL IMPLANT. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH IT WAS NOTED THAT MULTIPLE ATTEMPTS WERE MADE TO REPOSITION THE LEAD WITHOUT SUCCESS. DUE TO PATIENT CONDITION, THE PHYSICIAN ELECTED TO REMOVE THE ATRIAL LEAD, PLUG THE ATRIAL PORT AND CONVERT THE DEVICE TO A SINGLE CHAMBER PACEMAKER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization