BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3053119 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04413
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    June 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. VISUAL INSPECTION REVEALED THE INSULATION WAS CUT 277 MM FROM THE TERMINAL PIN. RESISTANCE TESTS WERE COMPLETED TO ASSESS THE ELECTRICAL PERFORMANCE OF THE LEAD. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD KEPT DISLODGING RESULTING IN UNSTABLE SENSING AND THRESHOLD MEASUREMENTS. THE HELIX WENT IN AND OUT AND WOULD NOT FIX TO THE TISSUE. THE PATIENT SUFFERED A HEMORRHAGE FOLLOWING POCKET CLOSURE. THE HEMORRHAGE WAS DRAINED AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155141 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R