BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3040813 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01061
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS LESS THAN 100 OHMS. THE RV LEAD DISPLAYED NOISE LESS THAN TWO SECONDS. THE PATIENT WAS REPORTEDLY NON-PACER DEPENDENT AND REPORTED SYMPTOMS OF MILD FATIGUE. THE PHYSICIAN ELECTED TO DECREASE THE RV SENSING. A REVISION PROCEDURE WAS PERFORMED. VISIBLE INSULATION BREAKDOWN WAS OBSERVED NEAR THE SUBCLAVIAN ACCESS. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144206 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 4538| 4088| 4087| H120