BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2811622 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16389
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 1, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. EVALUATION SUMMARY: (B)(4) A THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND VISUAL ANALYSIS NOTED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A PERICARDIAL EFFUSION AFTER IMPLANT. THE PATIENT COMPLAINED OF A "ZING" IN THE MIDDLE OF THE CHEST THAT SOUNDED LIKE DIAPHRAGMATIC STIMULATION. THE PATIENT WAS VERY UNCOMFORTABLE WITH RIGHT VENTRICULAR (RV) PACING AND THERE WAS NO CAPTURE ON THE RV LEAD. THE RV LEAD ALSO HAD DECREASED SENSING AND IMPEDANCE CHANGES. A SUBSEQUENT ECHOCARDIOGRAM SHOWED A SLIGHT PERFORATION OF 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
    1 CAPSUREFIX NOVUS MRI IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 5086MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R RVDR01 IMPLANTABLE PULSE GENERATOR| 5086MRI IMPLANTABLE PACING LEAD