BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2130750 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10231
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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) NO ANOMALIES FOUND; THE FULL LEAD WAS RETURNED FOR ANALYSIS. THE INNER INSULATION WAS KINKED/BUCKLED. BLOOD WAS OBSERVED IN/ON THE HELIX MECHANISM. THE LEAD WAS STRETCHED AND DAMAGED AT IMPLANT. EVALUATION SUMMARY (B)(4) FULL LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT IT WAS NOT POSSIBLE TO AFFIX THE HELIX TO THE HEART. THE LEAD WOULD MOVE EACH TIME THE HELIX WAS DEPLOYED. THE PHYSICIAN HELD BOTH THE LEAD BODY AND STYLET WHILE TURNING THE PINCH ON TOOL SLOWLY. WATCHING UNDER FLUOROSCOPY THE LEAD TIP "JUMPED" OUT OF PLACE EACH TIME. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS IMPLANTED. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other