BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3050115 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03545
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 22, 2013
    Report Date
    April 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED LEADS HAVE NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE LEADS WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED COIL DEFORMATION AND INSULATION DAMAGE, AS THE OUTER COIL OF THE LEAD WAS EXPOSED. THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATED STRESS OVER TIME. IN THIS CASE, WE BELIEVE THE STRESS WAS THE RESULT OF LEAD ON CAN CONTACT. THE REPORTED INCLUDE SPECIFIC CLINICAL OBSERVATION HERE, FOR EXAMPLE OVERSENSING WHICH RESULTED IN PACING INHIBITION FOR GREATER THAN TWO SECONDS OF AYSTOLE IS LIKELY THE RESULT OF THE LEAD DAMAGE OBSERVED BY THE LABORATORY. THE LEAD WAS ARCHIVED AT BOSTON SCIENTIFIC.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD WERE REMOVED AND REPLACED DUE TO AN INSULATION ISSUED OBSERVED DURING A RECENT FOLLOW UP VISIT. IN ADDITION, THE LEADS EXHIBITED OVERSENSING WHICH RESULTED IN PACING INHIBITION FOR GREATER THAN TWO SECONDS OF ASYSTOLE. THE LEADS WERE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148880 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R