BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2965051 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02117
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 11, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. FOLLOW UP WITH THE PATIENT'S CARDIOLOGIST REVEALED THE PHYSICIAN WANTS THE LEFT SIDE TO REMAIN AS A BACKUP SYSTEM UNTIL THE RIGHT SIDE SYSTEM IS STRONG ENOUGH. ONCE THE RIGHT SIDE SYSTEM IS STRONG ENOUGH, THE PHYSICIAN WILL EXPLANT THE SYSTEM ON THE LEFT. 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 ATRIAL AND VENTRICULAR LEAD IMPEDANCE WAS LOW AND EACH TRIGGERED A LEAD WARNING. THE PATIENT'S ENTIRE SYSTEM WAS REPLACED ON THE PATIENT'S RIGHT SIDE. THE OLD SYSTEM, LOCATED ON THE LEFT SIDE, REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69121 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068-52

    Patients

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