BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3051249 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04811
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    October 23, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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). PRODUCT: 6947-65 IMPLANTABLE TACHY LEAD (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD (RA) HAD LOSS OF SENSING AND LOSS OF CAPTURE. IT WAS NOTED THAT THE PATIENT WAS PART OF THE PAINFREE STUDY. THE RA LEAD WAS CAPPED 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
    153375 CAPSUREFIX DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6940

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D354DRG