BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2955439 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01448
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 4, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POTENTIAL PERFORATION FROM THE RIGHT VENTRICULAR (RV) LEAD. ALSO, THE RIGHT ATRIAL (RA) LEAD HAD POOR SENSING, IMPEDANCE AND THRESHOLD VALUES. IT WAS INDICATED THAT THE RA LEAD UNIPOLAR NUMBERS WERE SLIGHTLY BETTER THAN THE BIPOLAR. THE RV AND RA LEADS WERE BOTH CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58997 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR