BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1852943 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15403
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT CALLED BOSTON SCIENTIFIC PATIENT SERVICES (PS) TO STATE THAT THEIR RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED AND WAS CAUSING PAIN AROUND THE HEART WITH MOVEMENT. THE PATIENT STATED THAT THEY EXPLAINED THIS TO THEIR PHYSICIAN AND THE PHYSICIAN STATED THE LEAD WAS FINE. LATER, THE PATIENT FELT THE PAIN WAS SO GREAT THAT THEY CALLED AN AMBULANCE AND WENT TO THE EMERGENCY ROOM. DURING THE RIDE IN THE AMBULANCE THE PARAMEDIC DID AN EKG AND STATED THAT THE LEAD IN THE BOTTOM OF THE HEART IS NOT WORKING. ONCE THE PATIENT ARRIVED AT THE HOSPITAL, A SECOND EKG WAS PERFORMED WHICH SHOWED THE LEAD WORKING APPROPRIATELY. THE LEAD REMAINS IMPLANTED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 4088| S603| 4087