BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2864836 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17550
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 12, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THE PROXIMAL CONDUCTOR WAS FRACTURED AND WAS DISTORTED. ALL CONDUCTORS WERE STRETCHED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE INNER INSULATION WAS TORN. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES 5024 IMPLANTABLE PACING LEAD (B)(6) 1997, 4193 IMPLANTABLE PACING LEAD, (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. FOLLOW-UP ATTEMPTS WERE UNSUCCESSFUL AT YIELDING ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068

    Patients

    Seq Age Sex Outcome Treatment
    1 00092 YR Hospitalization| R 8042 IMPLANTABLE PULSE GENERATOR