BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2810825 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15801
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 7, 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) THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS FOUND ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND THE INNER INSULATION AND TUBING WERE BOTH KINKED/BUCKLED. BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM, AND THE LEAD APPEARED TO HAVE BEEN STRETCHED AND EXHIBITED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A DAY OF IMPLANT, THE RIGHT VENTRICULAR LEAD DISLODGED AND WAS UNABLE TO BE REPOSITIONED WITH ACCEPTABLE VALUES. THE LEAD WAS EXPLANTED AND WAS REPLACED WITH A NEW LEAD. NO 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 69 YR Hospitalization| R RVDR01 IMPLANTABLE PULSE GENERATOR| 5086MRI IMPLANTABLE PACING LEAD