BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2203233 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12092
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 1, 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. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE LEAD WAS FOUND TO BE STRETCHED. VISUAL ANALYSIS REVEALED THAT THE LEAD APPEARED TO BE DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT OF THE LEAD THE PHYSICIAN HAD TO REPOSITION THE LEAD IN MULTIPLE LOCATIONS OVER THE COURSE OF THIRTY TO FORTY MINUTES UNSATISFACTORY LEAD NUMBERS. IT WAS ALSO REPORTED THE HELIX MECHANISM WAS EXTENDED AND RETRACTED GREATER THAN TEN CYCLES THROUGH THE POSITIONING PROCESS AND THE PHYSICIAN WAS CONCERNED WITH THE LEAD PERFORMANCE. THE LEAD WAS NOT USED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED.

    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 69 YR Hospitalization| L| R