BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2053589 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04993
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    July 20, 2007
    Report Date
    March 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE EXPLANTED PRODUCTS HAVE NOT BEEN RETURNED FOR ANALYSIS. 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 FROM THE PATIENT THAT THIS PACING SYSTEM DID NOT WORK. THE PATIENT REPORTED THAT SHE HAD DEVELOPED AN INFECTION; THEREFORE, THE SYSTEM WAS NOT RECONNECTED TO THE HEART OR REPLACED. THE SYSTEM WAS EXPLANTED TWO MONTHS POST IMPLANT. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 4087| 1190