BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2811687 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17130
    Event Type
    Injury
    Date Received
    October 31, 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
    PA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS HAD HIGH THRESHOLDS AND THE RV LEAD CAUSED PHRENIC NERVE STIMULATION AND CHEST PAIN DURING PACING. BOTH LEADS WERE REPOSITIONED AND REMAIN IN USE WITH THRESHOLDS BELOW ONE VOLT AND NO NERVE STIMULATION. NO FURTHER PATIENT COMPLICATIONS WERE NOTED 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 70 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR