BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3160501 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-08040
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE INNER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO MIO (METAL ION OXIDATION) WHILE IN VIVO. IT WAS NOTED THAT THERE WAS BLOOD ON THE DISTAL AND PROXIMAL CONDUCTORS OF THE LEAD AND IT WAS OBSTRUCTED. THE OUTER INSULATION OF THE LEAD DEVELOPED COSMETIC MIO (METAL ION OXIDATION) WHILE IN VIVO. THE OUTER INSULATION OF THE LEAD DEVELOPED COSMETIC ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO.

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS EXHIBITING LOW IMPEDANCE, NO SENSING AT MAXIMUM SENSITIVITY, AND NON-CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW RA LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260870 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Hospitalization| R ADSR01 IMPLANTABLE PULSE GENERATOR