BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEXTRUS 4136

    MDR report key: 1944566 · Received December 16, 2010

    Report

    Report Number
    1028232-2010-02791
    Event Type
    Other
    Date Received
    December 16, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 13, 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 RECEIVED INFORMATION THAT THE PT WITH THIS PACEMAKER HAD RATES OBSERVED IN THE 30PPM RANGE. THE PT WAS RECENTLY IMPLANTED AND IS PACEMAKER DEPENDANT. TECHNICAL SERVICES STATED VVI 30 SOUNDS LIKE THE BACK UP RATE FOR AN INTRINSIC AMPLITUDE TEST. THE CALLER STATED THEY WOULD INVESTIGATE THIS FURTHER. THE CALLER ALSO QUESTIONED OVERSENSING AND LOSS OF CAPTURE WITH THE AUTOMATIC CAPTURE FEATURE, HOWEVER, THIS OBSERVATION WAS NOT PROVEN AT THE TIME OF THE CALL. BASED ON THE AVAILABLE INFORMATION, NO CHANGES TO THE PACING SYSTEM WERE MADE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    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 Other