BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4970399 · Received August 5, 2015

    Report

    Report Number
    2182208-2015-02440
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    May 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). 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: A HIGHLY EFFECTIVE TECHNIQUE FOR TRANSSEPTAL ENDOCARDIAL LEFT VENTRICULAR LEAD PLACEMENT FOR DELIVERY OF CARDIAC RESYNCHRONIZATION THERAPY. HEART RHYTHM. 2015;12(5):943-949. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING LEFT VENTRICULAR (LV) 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: LOSS OF CAPTURE, RISING PACING THRESHOLDS, ¿UNMANAGEABLE: PHRENIC NERVE STIMULATION, LEAD DISPLACEMENT. THERE WAS ALSO A NOTED PATIENT WITH LONGER THAN EXPECTED PROCEDURE TIME, AND ONE PATIENT WITH A HEMATOMA WHICH RESOLVED WITHOUT INTERVENTION. ANOTHER PATIENT REPORTEDLY HAD AN ISCHEMIC STROKE EPISODE, BUT RECOVERED COMPLETELY. THE ARTICLE FURTHER STATED THAT THREE (3) PATIENT WERE STARTED ON MEDICATION SPECIFICALLY FOR THE LEAD IMPLANT. THE STATUS OF THE LEADS IS UNKNOWN; HOWEVER, THE AUTHOR STATED THAT THE PROCEDURE WAS PERFORMED SUCCESSFULLY IN ALL 12 CASES. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513008 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| L| R 6227DEF SHEATH