BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3212943 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10300
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 15, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION REVEALED BLOOD/BODY FLUID IN THE HELIX MECHANISM. THE HELIX DID NOT APPEAR BENT. THE INSULATION IN THE NEXK REGION OF THE LEAD WAS TWISTED AND THE LEAD TIP WAS BENT APPROXIMATELY TEN DEGREES IN THE MOLDED NECK BETWEEN THE DISTAL RING AND THE HELIX MECHANISM.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS DISLODGED. IN ADDITION, INCREASED THRESHOLD MEASUREMENTS WERE OBTAINED. A REVISION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, DURING THE ATTEMPT TO REPOSITION THIS LEAD, THE HELIX WOULD NOT EXTEND APPROPRIATELY. A DECISION WAS MADE TO REPLACE THIS LEAD. UPON REMOVAL, VISUAL OBSERVATION REVEALED THE LEAD TIP WAS BENT, HOWEVER THE HELIX COULD BE EXTENDED. THIS LEAD WAS SUCCESSFULLY REPLACED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313261 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R