BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2042084 · Received March 29, 2011

    Report

    Report Number
    1028232-2011-00625
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    January 28, 2011
    Report Date
    March 14, 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 CRM REC'D INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE. THE PT HAD AN UNDERLYING RATE OF 30BPM. A CHEST X-RAY NOTED THE LEAD WAS PAST THE TRICUSPID. DURING THE REPOSITIONING, THE HELIX WOULD NOT RETRACT. THE HELIX FINALLY RETRACTED, HOWEVER, IT WOULD NOT EXTEND. AS A RESULT, THIS LEAD WAS EXPLANTED. NO ADVERSE PT EFFECTS WERE NOTED. THIS LEAD WAS ABANDONED, THEREFORE, BOSTON SCIENTIFIC CRM WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT 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 Hospitalization