BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2131075 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10374
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD HAD A POSSIBLE FRACTURE. THE LEAD HAD CONTINUED HIGH IMPEDANCE AND NOISE. THE LEAD WAS CAPPED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE ON THE ATRIAL LEAD. THE DEVICE WAS REPROGRAMMED TO CHANGE SENSITIVITY OF LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R