BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990665 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08553
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. THE ANALYST COMMENTED THAT ELECTRICAL RESISTANCE AND CROSS CONTINUITY TEST RESULTS WERE WITHIN SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR DAYS POST IMPLANT THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS WERE FOUND TO BE DISLODGED ON X-RAY. THERE WAS NOISE ON THE RV ELECTROGRAM, RV SIGNALS WERE OBSERVED ON THE RA ELECTROGRAM, AND THE RV LEAD DID NOT CAPTURE AT HIGH OUTPUT. THE RA LEAD EXHIBITED HIGH/UNSTABLE THRESHOLDS AND OVERSENSING/NOISE. THE RV LEAD WAS REPOSITIONED AND REMAINS IN USE, AND THE RA LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467729 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R DTBB1D4 ICD, 4196 LEAD, 6935M LEAD