BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2964405 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01990
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 19, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. CONTINUED: (B)(4)IMPLANTABLE PACING LEAD (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NOTED THAT THE PROXIMAL CONDUCTOR WAS FRACTURED AT THE 1ST RIB/CLAVICLE LOCATION AND THAT THE OUTER INSULATION WAS CUT AND BREACHED AT THE SAME LOCATION. ANALYSIS ALSO NOTED BLOOD ON THE PROXIMAL AND DISTAL CONDUCTOR OF THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXHIBITED SYMPTOMS OF CONGESTIVE HEART FAILURE (CHF) RESULTING FROM ATRIAL LEAD NOT SENSING AND NOT PROPERLY PACING. IT WAS NOTED THERE WAS HIGH IMPEDANCE, NOISE AND POSSIBLE FRACTURE ON THE LEAD. THE LEAD WAS EXPLANTED 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
    66953 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

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