BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2813635 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17279
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S46
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) BATTERY DEPLETED EARLIER THAN EXPECTED. ALSO REPORTED WAS WORSENING AND NOW HIGH RIGHT ATRIAL THRESHOLD. THE ICD WAS EXPLANTED AND REPLACED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5594

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R 6945 IMPLANTABLE TACHY LEAD