BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 2051217 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05510
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 7, 2011
    Report Date
    November 4, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE. THE ANALYST INDICATED THAT ATRIAL PACE IMPEDANCE WAS CONSISTENTLY LOW AT APPROXIMATELY 115 OHMS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAS HAD DECREASING AND LOW IMPEDANCE LEVELS THAT TRIGGERED THE ATRIAL LEAD IMPEDANCE WARNING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2015, 08:40:00, LYDDOE1: IT WAS FURTHER REPORTED AN ADDITIONAL ATRIAL LEAD IMPEDANCE WARNING WAS TRIGGERED. ENVIRONMENTAL STRESS CRACKING OR INSULATION WEAR WAS SUSPECTED. APPROXIMATELY FOUR MONTHS LATER DURING A ROUTINE DEVICE CHANGE OUT, THE RIGHT ATRIAL (RA) LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAS HAD DECREASING AND LOW IMPEDANCE LEVELS THAT TRIGGERED THE ATRIAL LEAD IMPEDANCE WARNING. THE LEAD REMAINS IN USE. 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 4568 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB