BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 2790578 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15040
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Report Date
    March 15, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED. ANALYSIS INDICATED THAT THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO ENVIRONMENTAL STRESS CRACKING WHILE IN VIVO. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD SHOWED NOISE OVERSENSING ON AN ATRIAL HIGH RATE EPISODE. THE NOISE WAS REPRODUCIBLE DURING ISOMETRIC TESTING IN THE OFFICE. THE LEAD REMAINS IN USE AND CONTINUES TO BE MONITORED. 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 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE DTB MEDTRONIC PUERTO RICO, INC. 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other 5076 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR