BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS LEAD

    MDR report key: 9398460 · Received December 2, 2019

    Report

    Report Number
    2182208-2019-02159
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    September 9, 2019
    Report Date
    December 2, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: LONG-TERM PERFORMANCE OF AN ATRIAL LEAD CAPABLE OF ACCELEROMETER BASED DETECTION OF CARDIAC CONTRACTILITY IN PATIENTS RECEIVING CARDIAC RESYNCHRONIZATION THERAPY PLOS ONE. 2019; 14(9). 10.1371/JOURNAL.PONE.0222269. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING AN ATRIAL PACING LEAD. THE AUTHORS DISCUSSED AN INCREASE IN ATRIAL PACING THRESHOLDS WHICH WAS NOT MEASURABLE. THE LEAD WAS REPLACED. THE DISPOSITION OF THE LEAD IN QUESTION IS NOT KNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189864 CAPSURE SP NOVUS LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R