BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1771424 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12540
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 10, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE. SHOULD FURTHER INFORAMTION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS REPOSITIONED DUE TO ELEVATED THRESHOLDS AND LOW SENSING. THE PHYSICIAN NOTED THE LEAD APPEARED TO HAD BEEN MICRO-DISLODGED DUE TO PATIENT ACTIVITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R S603| 4086| 4087