BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1853216 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14395
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 16, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC CRM. SHOULD ADDITOINAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER WAS EXPLANTED DUE TO A POSSIBLE INFECTION AND/OR ALLERGIC REACTION. THE RIGHT VENTRICULAR LEAD MAY NEED TO BE EXPLANTED IN THE NEAR FUTURE.

    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 Other