BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2042040 · Received March 29, 2011

    Report

    Report Number
    1028232-2011-00629
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    January 31, 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 REC'D INFORMATION THAT FOLLOWING IMPLANT OF THIS PACING SYSTEM, THIS PT COMPLAINED OF CHEST DISCOMFORT. AN X-RAY AND ECHOCARDIOGRAM WERE BOTH UNREMARKABLE FOR ANY ISSUES AND DIAGNOSTIC TESTING PRODUCED APPROPRIATE RESULTS. TWO DAYS LATER, THE PT WAS STILL EXPERIENCING PAIN AND A PERICARDIAL EFFUSION WAS REVEALED DUE TO A SUSPECTED PERFORATION. A REVISION PROCEDURE WAS PERFORMED AND THE PHYSICIAN ELECTED TO REPOSITION BOTH OF THIS PT'S DEXTRUS LEADS. AN ECHOCARDIOGRAM FOLLOWING THE PROCEDURE SHOWED NO FURTHER ISSUES. THIS EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS REC'D.

    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