BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2203475 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11700
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    April 17, 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
    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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND PRIMARY ANALYSIS REVEALED NO ANOMALIES FOUND. THERE WAS BLOOD/BODY FLUID PRESENT ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND IN/ON THE HELIX/LOBE MECHANISM. THE OUTER INSULATION WAS BREACHED CUT. THE HELIX/LOBE WAS DISTORTED/BENT. THERE WAS ALSO APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SIDE PAIN A FEW WEEKS AFTER INITAL IMPLANT. AN X-RAY INDICATED THAT THE LEAD HAD DISLODGED AND HIGH THRESHOLDS WERE MEASURED. DURING LEAD EXTRACTION, THE PHYSICIAN NOTED TISSUE ON THE HELIX. THE LEAD WAS REMOVED 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R