BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 3053141 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04587
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED INSULATION ABRASION. LAB TECHNICIANS CONFIRMED TWO INSULATION ABRASIONS THROUGH TO THE ANODE CONDUCTOR COIL ON OPPOSING SIDES OF THE LEAD, BETWEEN 63 AND 68MM FROM THE TERMINAL PIN. DUE TO THE LOCATION AND TYPE OF ABRASIONS, IT APPEARS THAT THE ABRASIONS WERE CAUSED BY LEAD-ON-LEAD AND LEAD-ON-CAN CONTACT WITHIN THE POCKET AREA. THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATED STRESS OVER TIME. THE REPORTED MYOPOTENTIALS IS LIKELY THE RESULT OF THIS OBSERVED LEAD BODY DAMAGE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS EXPLANTED DUE TO A CLINICAL OBSERVATION OF MYOPOTENTIALS. NO ADVERSE PATIENT EFFECTS REPORTED AND THE LEAD WAS RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156396 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR P108| MISMATCH| 4096| 0296