BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3040762 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01596
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 8, 2013
    Report Date
    September 19, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SUBSEQUENTLY RETURNED FOR TESTING. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION DID NOT IDENTIFY ANY LEAD ABNORMALITIES. RESISTANCE AND PRESSURE TESTING CONFIRMED THE ELECTRICAL CONTINUITY AND INSULATION INTEGRITY OF THE LEAD. FINAL ANALYSIS COULD NOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    THE LEAD WILL NOT BE RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD TWIDDLED THIS ATRIAL LEAD TO THE POINT OF A FRACTURE AND NOW THE LEAD WAS PROTRUDING THROUGH THIS PATIENT'S SKIN. THERE WERE NO INAPPROPRIATE EPISODES STORED, NO INAPPROPRIATE THERAPY OR SYMPTOMS NOTED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143291 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization 4086| E110| 0184