BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3050087 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03427
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    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 RIGHT ATRIAL (RA) LEAD PACING IMPEDANCE WAS GREATER THAN 2,500 OHMS, WITH INCREASED THRESHOLD MEASUREMENTS. UPON XRAY, A POSSIBLE LEAD FRACTURE WAS OBSERVED, WITH SUSPECTED TRAUMA TO THE SITE. THE PATIENT WITH THIS SYSTEM WAS ENDURING CHRONIC ATRIAL FIBRILLATION (AF), THEREFORE, THE DEVICE WAS PROGRAMMED TO VVIR. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148036 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 4088| 4086| 1294| 1291| 4087