BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2150959 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06298
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    July 15, 2010
    Report Date
    October 5, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED IN (B)(4) 2011 THAT THIS LEAD HAD NOT BEEN EXPLANTED IN 2010 AS ORIGINALLY REPORTED. THE PHYSICIAN HAD JUST CUT THE LEADS AND THEY REMAINED IN THE PATIENT. OVER TIME, THE SUTURE SLEEVES FELL OFF THE LEADS AND MIGRATED UP TO THE POCKET AREA AND STARTED TO ERODE THROUGH THE PATIENT'S SKIN. THE POCKET WAS RECENTLY REOPENED TO EXPLANT THESE PREVIOUSLY ABANDONED LEADS. HOWEVER, WHEN THE POCKET WAS OPENED, THE SUTURES SLEEVES FELL ON THE FLOOR AND THE LEADS COULD NOT BE ACCESSED AND REMAIN IN THE PATIENT'S BODY. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD BEEN EXPERIENCING A STINGING SENSATION NEAR HIS PACEMAKER POCKET. THE SENSATION WAS ONLY OCCURRING ONCE IN A WHILE FOR APPROXIMATELY ONE SECOND, TWO TO THREE TIMES PER DAY. (B)(6) LATER, IT WAS REPORTED THAT THIS PACEMAKER HAD ERODED THROUGH THIS PATIENT'S SKIN. THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED WITHOUT FURTHER INCIDENT.

    Description of Event or Problem · 1

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    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 72 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)| (B)(4)