BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2864881 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17598
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED. PERFORMANCE DATA WERE COLLECTED FROM THE DEVICE AND ANALYZED. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MAXIMUM ATRIAL PACING IMPEDANCE MEASUREMENTS FROM 520 OHMS TO 16382 OHMS BETWEEN (B)(6) 2011 AND (B)(6) 2012.

    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: 6945 IMPLANTABLE DEFIBRILLATION LEAD, (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEVICE CHANGE OUT, THE LEAD WAS CAPPED AS THE PATIENT IS IN CHRONIC ATRIAL FIBRILLATION. IT WAS NOTED THE LEAD HAD HIGH IMPEDANCE MEASUREMENTS AND THERE WAS AN INSULATION BREACH WITH EXPOSED WIRE. 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6940

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R 7278 IMPLANTABLE CARDIAC DEFIBRILLATOR (B)(6) 2007