BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX LEAD

    MDR report key: 2951746 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00208
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    April 13, 2020
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. CONCOMITANT PRODUCT: 6942 IMPLANTABLE TACHY LEAD, (B)(6) 2001. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED: PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE ANALYSIS INDICATED THAT THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH AT THE FIRST RIB/CLAVICLE LOCATION WHILE IN VIVO. THE ANALYST NOTED THAT THE PROXIMAL CONDUCTOR WAS FRACTURED AT 26.3 CM AND THE OUTER INSULATION WAS BREACHED AT 26 AND 29 CM FROM THE CONNECTOR PIN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIUM (RA) LEAD WAS PERIODICALLY SENSING FAR-FIELD R-WAVES AND HAD INTERMITTENT UNDERSENSING OF P-WAVE. THEREFORE THE RA LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56687 CAPSUREFIX LEAD DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6940-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R D154ATG IMPLANTABLE PACEMAKER CARDIO/DEFIB