BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2170775 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10294
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    August 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PROXIMAL LEAD SEGMENT WAS PERFORMED. THE LEAD WAS RETURNED SEVERED 34.5 CENTIMETERS FROM PIN, AND THE PROXIMAL SEGMENT ONLY WAS RETURNED. NO SIGNS OF DAMAGE IN THE INSULATION AT 30 CENTIMETERS FROM THE PIN OR ANYWHERE ELSE ON RETURNED SEGMENT OF LEAD WERE NOTED. ADDITIONALLY, NO COIL FRACTURES WERE OBSERVED ON THE LEAD SEGMENT. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES ON THE RETURNED SEGMENT OF THE LEAD.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS EXPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE FALLING IMPEDANCE MEASUREMENTS OVER TIME, FALLLING TO BELOW 200 OHMS. ADDITIONALLY, THE PATIENT BEGAN EXPERIENCING DIAPHRAMATIC STIMULATION. THE PHYSICIAN ALSO NOTED THE LEAD DISPLAYED INSULATION DAMAGE. DURING THE EXPLANT PROCEDURE, THE LEAD FRACTURED 30 CENTIMETERS DOWN THE LEGNTH OF THE LEAD. THE LEAD WAS REPLACED WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    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 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R 1290| S606| 4136| 4088| 4087