BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE

    MDR report key: 5011898 · Received August 18, 2015

    Report

    Report Number
    2182208-2015-03052
    Event Type
    Injury
    Date Received
    August 18, 2015
    Date of Event
    July 1, 2015
    Report Date
    August 5, 2015
    Manufacturer
    MEDTRONIC, PLC
    Product Code
    NVN
    PMA / PMN Number
    P0800006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND SUBSEQUENT FOLLOW UP. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF 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. REFERENCED ARTICLE: HIS-BUNDLE PACING VERSUS BIVENTRICULAR PACING IN CARDIAC RESYNCHRONIZATION THERAPY PATIENTS: A CROSSOVER DESIGN COMPARISON. HEART RHYTHM. 2015;12(7):1548-1557.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS MODEL OF IMPLANTABLE PACING LEADS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT THERE WERE THE FOLLOWING LEAD ISSUES: PLACEMENT ISSUES AND LEAD DISLODGEMENT. THE STATUS OF THE LEADS IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545245 SELECTSECURE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, PLC 3830

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention