BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2130915 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10301
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THE PATIENT EXPERIENCED CHEST PAIN (B)(6) POST DEVICE IMPLANT. THE RIGHT VENTRICULAR [RV] LEAD SHOWED DIMINISHED P-WAVES (UNDERSENSING) AND AN ECHOCARDIOGRAM REVEALED AN RV APICAL/SEPTAL PERFORATION. THE RV LEAD WAS REPOSITIONED AND REMAINS IN USE. THE ATRIAL LEAD WAS ALSO REPOSITIONED, BUT SATISFACTORY THRESHOLD RESULTS COULD NOT BE ACHIEVED. THE LEAD WAS EXTRACTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR