BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2169445 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10183
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE LEAD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC 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.

    Additional Manufacturer Narrative · 1

    THE COMPLETE LEAD WAS RETURNED. THE HELIX WAS EXTENDED, STRETCHED AND HAD DRIED BODY TISSUE ENTWINED IN IT. THE CONDUCTOR COILS WERE NOTED TO BE DEFORMED 52-56 MILLIMETERS (MM) FROM THE TERMINAL PIN. THIS DAMAGE WAS ATTRIBUTED TO A GRABBING TOOL. THE CONDUCTOR COILS WERE ALSO STRETCHED 52-80 MM FROM THE TERMINAL PIN. THERE WERE NUMEROUS CUTS NOTED IN THE INSULATION THROUGHOUT THE LEAD. AN ABRASION WAS SEEN 192-195 MM FROM THE TERMINAL PIN. THE DAMAGE WAS DISTAL TO AND UNDER ONE OF THE TWO SUTURE SLEEVES THAT WERE ON THE LEAD. INSULATION BETWEEN ANODE RING AND HELIX HOUSING WAS TWISTED. TESTING ON THE LEAD WAS PERFORMED. A STYLET WAS NOT ABLE TO BE INSERTED PAST 192 MM FROM THE TERMINAL PIN. THE LEAD WAS DETERMINED TO BE ELECTRICALLY CONTINUOUS. IT WAS DETERMINED THAT THE CLINICAL OBSERVATIONS COULD HAVE BEEN CAUSED BY THE DAMAGE THAT WAS SEEN ON THE LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT INTERMITTENT LACK OF RIGHT VENTRICULAR (RV) PACING AND LONG PAUSES WERE OBSERVED ON THE ELECTROGRAM (ECG). UPON INTERROGATION OF THE DEVICE SYSTEM, ALL LEAD MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS, WITH NO NOISE PRESENT. THE PATIENT'S PHYSICIAN SUSPECTED AN INTERMITTENT LEAD MALFUNCTION DUE TO POSSIBLE FIRST RIB CLAVICULAR CRUSH OR A VERY TIGHT SUTURE SLEEVE. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD AND DEVICE WERE SUCCESSFULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE PROCEDURE.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED FOR ANALYSIS.

    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 4087| S603| 4086| 4459| 1298