BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2033173 · Received February 28, 2011

    Report

    Report Number
    1028232-2011-00443
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    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 REC'D INFO THAT A LEAD REVISION PROCEDURE WAS PERFORMED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH THRESHOLD MEASUREMENTS. DURING THE REVISION PROCEDURE THE PHYSICIAN WAS UNABLE TO REPOSITION THE LEAD DUE TO SCAR TISSUE BUILD-UP. THE RV LEAD WAS SURGICALLY ABANDONED AND A LEAD WAS SUCCESSFULLY IMPLANTED. IT WAS NOTED THAT PRIOR TO THE LEAD REVISION THE PT DID EXPERIENCE SYNCOPE, HOWEVER, THE PHYSICIAN STATED THAT THE PT HAS MULTIPLE COMORBIDITIES. NO SPECIFIC MEASUREMENTS WERE PROVIDED AND NO ADVERSE PT EFFECTS WERE REPORTED. AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED. DESPITE THE STATEMENT THAT THIS LEAD WAS SURGICALLY ABANDONED, AN EXPLANT DATE WAS 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