BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4160755 · Received October 10, 2014

    Report

    Report Number
    3008973940-2014-00392
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 18, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, AND ANALYZED. A PROXIMAL PORTION WAS RECEIVED MEASURING 8 CM. A DISTAL PORTION WAS RECEIVED MEASURING 52 CM. THE HELIX OF THE LEAD WAS EXTRINSICALLY COMPRESSED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO UNSCREW FROM THE VENTRICLE, AND THEREFORE IT WAS NOT POSSIBLE TO WITHDRAW THE LEAD. AS A RESULT, THE RV LEAD WAS CUT, AND A SHEATH WAS USED TO SLOWLY WITHDRAW THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641735 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R