BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 2911364 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15806
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 21, 2012
    Report Date
    January 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE LEAD WAS SEVERED 62MM FROM THE TERMINAL PIN. AS ONLY THE PROXIMAL COIL WAS RETURNED, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    IT WAS INDICATED THIS LEAD WOULD NOT BE RETURNED. 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

    SUBSEQUENT INFORMATION WAS RECEIVED THAT INDICATED THE NOISE WAS OVERSENSED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, NOISE WAS NOTED ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD. THE NOISE COULD BE RECREATED ON THE RA LEAD. THE PACING IMPEDANCE MEASUREMENTS WERE BOTH OUT OF RANGE. THE THRESHOLD MEASUREMENT ON THE RV LEAD WAS TOO HIGH TO MEASURE. IT WAS SUSPECTED THAT SUBCLAVIAN CRUSH WAS CAUSING THE LEAD ISSUES; HOWEVER, AS THE DEVICE IS PART OF THE SUBPECTORAL IMPLANT POPULATION, A DEVICE ISSUE CANNOT BE NEGATED. AN INVESTIGATIONAL PROCEDURE WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THAT THE DEVICE, RA AND RV LEADS WERE EXPLANTED. A NEW SYSTEM WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18228 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1