BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2051418 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05557
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    January 17, 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
    OH, 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) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. PRIMARY RESULTS REVEALED THAT NO ANOMALIES WERE FOUND. OUTER INSULATION HAD COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD REMNANT WAS DISSECTED OUT BUT COULD NOT BE REMOVED DUE TO FIBROSIS IN THE VEIN. THE LEAD REMNANT WAS CAPPED. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R E2SR01 IMPLANTABLE PULSE GENERATOR