BEUDAMED
    FDA Adverse Event Death Summary report: N

    2124215-2011-08067

    MDR report key: 2080931 · Received May 8, 2011

    Report

    Report Number
    2124215-2011-08067
    Event Type
    Death
    Date Received
    May 8, 2011
    Date of Event
    December 9, 2010
    Report Date
    April 12, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN CONCLUSION , ELECTRONIC REPROGRAMMING WAS AN IMPORTANT TOOL IN THE MANAGEMENT OF CRT PATIENTS WHICH HELPED TO LOWER PACING THRESHOLDS, AVOIDED PHRENIC NERVE STIMULATION AND PREVENTED UNNECESSARY REOPERATIONS FOR LV LEAD REPOSITIONING. CHAMPAGNE J, HEALEY JS, KRAHN AD, PHILIPPON F, GUREVITZ O, SWEARINGEN A, GLIKSON M. THE EFFECT OF ELECTRONIC REPOSITIONING ON LEFT VENTRICULAR PACING AND PHRENIC NERVE STIMULATION. EUROPACE. 2011 JAN 26: EPUB BEFORE PRINT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A JOURNAL ARTICLE INVOLVING A STUDY THAT EXAMINED HOW PHRENIC NERVE STIMULATION AND HIGH PACING THRESHOLDS ARE COMMON PROBLEMS THAT LIMITED CARDIAC RESYNCHRONIZATION THERAPY (CRT) EFFECTIVENESS. THE AIM OF THIS PROSPECTIVE STUDY WAS TO EXAMINE THE CLINICAL UTILITY OF CRT SYSTEMS WITH MULTIPLE, PROGRAMMABLE PACING CONFIGURATIONS IN DEALING WITH HIGH PACING THRESHOLDS AND PHRENIC NERVE STIMULATION, BOTH AT IMPLANTATION AND DURING FOLLOW-UP. PATIENTS WERE IMPLANTED WITH CONTAK RENEWAL 2, 4, 4HE, 3RF HE AND 4AVT OR CONTAK RENEWAL TR2 WHICH WERE CAPABLE OF SIX DIFFERENT LV PACING CONFIGURATIONS. ALL IMPLANTED LV LEADS WERE BIPOLAR LEADS. OF THE 260 PATIENTS ORIGINALLY CONSENTED FOR THE STUDY, 32 PATIENTS HAD UNSUCCESSFUL LV LEAD IMPLANTS AND THEIR OUTCOME WAS NOT PART OF THE STUDY PROTOCOL. OF THE REMAINING 228 PATIENTS, THERE WERE NINE PATIENT DEATHS DURING THE STUDY (EIGHT CARDIAC AND ONE UNKNOWN). DEATHS WERE CLASSIFIED AS PERI-OPERATIVE IF THE DEATH OCCURRED 30 DAYS FROM THE IMPLANT, AND POST-OPERATIVE IF 30 DAYS AFTER IMPLANT. THERE WAS ONE SUDDEN CARDIAC DEATH IN THE PERI-OPERATIVE PERIOD, WHICH WAS CLASSIFIED AS UNRELATED TO THE DEVICE OR PROTOCOL BY THE INVESTIGATOR. IN THE POST-OPERATIVE PERIOD, FOUR CARDIAC DEATHS WERE CLASSIFIED AS SUDDEN, WITH THE REMAINING THREE AS NON-SUDDEN. THE UNKNOWN CAUSE OF DEATH OCCURRED IN THE POST-OPERATIVE PERIOD. THERE WERE A TOTAL OF 16 REVISION PROCEDURES IN 15 PATIENTS FOR LV LEAD DISLODGEMENT, DEVICE-RELATED ISSUES (SETSCREW, ADVISORY) AND RIGHT ATRIAL (RA)/RIGHT VENTRICULAR (RV) LEAD DISLODGEMENTS. ADDITIONALLY, A SUB-STUDY INVOLVING 5 CENTERS (48 PATIENTS) THAT PROVIDED A MORE DETAILED ASSESSMENT OF PHRENIC NERVE STIMULATION DURING IMPLANT AND FOLLOW-UP WAS CONDUCTED. THE SUB-STUDY COLLECTED DATA TO DESCRIBE THE R-WAVE AMPLITUDE, IMPEDANCE, LV PACING THRESHOLD, AND PHRENIC NERVE STIMULATION THRESHOLDS AT DIFFERENT BODY POSITIONS AT EACH FOLLOW-UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVN GUIDANT PUERTO RICO BV BRADY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R