BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1873871 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17782
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 31, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE SYSTEM REMAINS IN SERVICE, NONE OF THE PRODUCTS WILL BE RETURNED FOR ANALYSIS AND BOSTON SCIENTIFIC CRM CANNOT CONFIRM THE CLINICAL OBSERVATION. THERE IS NO ADDITIONAL INFORMATION RELATED TO THIS EVENT AVAILABLE, OR TO THE COMPANY AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE WITH THIS RIGHT ATRIAL (RA), THE PLACEMENT OF THE LEAD HAD BEEN DIFFICULT, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SOLID LEAD MEASUREMENTS. DURING THE DISCHARGE CHECK ON THE FOLLOWING DAY, THE P-WAVE AMPLITUDE HAD FALLEN FROM 3.8MV TO 0.4MV AND THE R-WAVE AMPLITUDE HAD ALSO DECREASED FROM 17.5MV TO 3.9MV. THE THRESHOLD COULD NOT BE DETERMINED ON THE RA LEAD. THREE DAYS LATER, A CHEST X-RAY CONFIRMED RA LEAD DISLODGEMENT INTO THE ATRIUM. SOME CONCERN WAS EXPRESSED ABOUT THE INTEGRITY OF THE FIXATION HELIX ON THIS LEAD AND WHETHER IT HAD BEEN FULLY EXTENDED DURING THE IMPLANT OR PERHAPS FAULTY. THE PHYSICIAN ELECTED TO REPROGRAM THE DEVICE TO VVI-40 UNTIL THE PATIENT RETURNED FOR A REVISION PROCEDURE. ONE WEEK LATER, THE PATIENT RETURNED FOR THE PROCEDURE AND ALSO COMMENTED THAT HE MAY HAVE RECEIVED A SHOCK FROM THE DEVICE. THE LOCAL CARDIAC TECHNICIAN AND A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT INTERROGATED BOTH THE PATIENT AND THE DEVICE. IT WAS CONFIRMED THAT NO SHOCK WAS DELIVERED SINCE IMPLANT TESTING; HOWEVER, THE PATIENT LIKELY VASODILATED DURING A HOT SHOWER AND BECAME HYPOTENSIVE. UPON PRE-PROCEDURE TESTING, ATRIAL PACING WAS UNABLE TO BE ESTABLISHED AND AMPLITUDES REMAINED POOR FOR THE ATRIAL LEAD. THE R-WAVE AMPLITUDE HAD RECOVERED TO STABLE LEVELS. A LARGE HEMATOMA WAS ALSO OBSERVED SURROUNDING THE DEVICE. THE PHYSICIAN ELECTED TO REPOSITION BOTH LEADS, AND CONFIRMED SUFFICIENT CONNECTION BETWEEN EACH OF THE LEADS AND THE DEVICE HEADER. FLUOROSCOPY CONFIRMED BOTH HELIX MECHANISMS WERE FULLY EXTENDED. FINAL LEAD MEASUREMENTS WERE SOLID FOR BOTH THE RA AND RIGHT VENTRICULAR (RV) LEADS. A SUCCESSFUL DFT WAS CONDUCTED WITH 26 JOULES CONVERTING THE INDUCED ARRYTHMIA. THE PHYSICIAN REPORTED SATISFACTION WITH THE DEVICE SYSTEM AND FUNCTION, AND THAT THE RA LEAD DISLODGEMENT HAD JUST BEEN AN UNFORTUNATE CIRCUMSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 0185| F110| 4096