BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2051720 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04027
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 20, 2011
    Report Date
    February 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD VISITED THE EMERGENCY ROOM (ER) AFTER FEELING "THUMPING" IN THEIR CHEST. IT WAS NOTED THAT LEAD IMPEDANCES WERE OKAY; HOWEVER, P AND R WAVES WERE UNABLE TO BE MEASURED. THERE WAS NO ATRIAL OR RIGHT VENTRICULAR (RV) CAPTURE AT MAXIMUM OUTPUT, BUT IT WAS NOTED THAT THIS PATIENT WAS NOT PACEMAKER DEPENDANT. IT WAS NOTED THAT A REVISION PROCEDURE WOULD BE PERFORMED IN THE NEAR FUTURE TO REPOSITION THE LEADS. ADDITIONAL INFORMATION WAS PROVIDED THAT A CHEST X-RAY CONFIRMED THIS LEAD HAD DISLODGED DUE TO THE PATIENT TWIDDLING THE LEAD. THE LEAD WAS SUBSEQUENTLY REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention E110| 4086| 0184