BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3223578 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10471
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPORTED CHEST PAIN AFTER INITIAL IMPLANT. THE PAIN WORSENED AND MILD DYSPNEA WAS ALSO NOTED. THE PATIENT WAS READMITTED TO THE HOSPITAL AND WAS DIAGNOSED WITH HEMOTHORAX, WHICH WAS TO BE TREATED CONSERVATIVELY AS SONOGRAPHY ONLY SHOWED A SMALL AMOUNT OF BLOOD AND THERE WAS NO SIGN OF SEVERE INTERNAL BLOOD LOSS AS CONFIRMED BY BLOOD ANALYSIS. THE PATIENT RECOVERED; HOWEVER, DURING THEIR MOST RECENT FOLLOW UP, RV SENSING WAS NOTED TO BE SIGNIFICANTLY DECREASED AND AN RV EXIT BLOCK WAS OBSERVED. A CHEST X-RAY CONFIRMED A POSSIBLE PERFORATION OF THE RIGHT VENTRICLE BY THE RV LEAD. THOUGH PACING INHIBITION WAS OBSERVED, THIS HAD NOT BEEN HEMODYNAMICALLY RELEVANT SINCE LEFT VENTRICULAR (LV) PACING HAD BEEN EFFECTIVE ALL THIS TIME. RV LEAD DISLODGEMENT AND LOSS OF CAPTURE WERE ALSO NOTED. THE DEVICE WAS REPROGRAMMED TO LV PACING PRIOR TO LEAD REVISION. THE RV LEAD WAS THEN REPOSITIONED WITH GOOD MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324214 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R