BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 2072606 · Received April 22, 2011

    Report

    Report Number
    1028232-2011-00925
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    January 17, 2011
    Report Date
    April 13, 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 MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG 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 MFG.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THE PT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND TRANSVENOUS LEAD UNDERWENT LUMBAR BACK SURGERY FOR OSTEOMYELITIS ON THEIR VERTEBRAE. THERE WAS CONFIRMED VEGETATION ON THEIR LEADS AND IT WAS THOUGHT THAT THIS PT MIGHT HAVE A SYSTEMIC INFECTION. ALL PRODUCTS WERE REMOVED FROM SERVICE. NO FURTHER PT EFFECTS WERE REPORTED. THE REPRESENTATIVE WAS UNSURE IF THE HOSPITAL WOULD RETURN THE PRODUCTS. INVESTIGATION IS COMPLETED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization