BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2905552 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-13622
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THE PATIENT WITH THIS IMPLANTABLE LEAD EVALUATED IN THE CLINIC AFTER A REPORT FALL SHORTLY AFTER THE PATIENT'S SYSTEM WAS IMPLANT. THE PATIENT WAS ASSISTED UP BY HAVING SOMEONE PULL ON HER LEFT ARM. AS A RESULT THERE WAS NO SENSING AND LOSS OF CAPTURE EXHIBITED. THE PATIENT FELT DIZZY; HOWEVER, HAD AN UNDERLYING RHYTHM. THE PATIENT WAS ADMITTED INTO THE HOSPITAL AND WAS TO HAVE A CHEST X-RAY PERFORMED AND A POSSIBLE LEAD REVISION PROCEDURE. ADDITIONAL INFORMATION INDICATES THAT BOTH OF THE PATIENT'S LEADS HAD DISLODGED AND THE PATIENT UNDERWENT A SUCCESSFUL REVISION PROCEDURE AND THIS PRODUCT WAS EXPLANTED AND REPLACED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10801 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R 4087| S603| 4088