BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2865101 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17635
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 19, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    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: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DAYS POST THE IMPLANT PROCEDURE THE PATIENT COMPLAINED OF SYNCOPE. HIGH THRESHOLDS AND A LOSS OF CAPTURE WERE OBSERVED AND REPORTED IN THE PACING LEAD. DURING THE ATTEMPT TO REPOSITION THE LEAD, THE HELIX WAS UNABLE TO RETRACT. THE LEAD WAS INACTIVATED AND A NEW LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R