BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2053092 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-05026
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PHYSICIAN OBSERVED THIS RIGHT VENTRICULAR LEAD'S THRESHOLD MEASUREMENTS TO BE HIGH. THE PHYSICIAN DECIDED TO REPLACE THE LEAD BECAUSE THE PATIENT IS DEPENDENT ON THE PACEMAKER'S THERAPY. THE IMPLANTABLE PULSE GENERATOR WAS ALSO REPLACED DURING THE PROCEDURE AFTER TAKING INTO CONSIDERATION THE REMAINING BATTERY LIFE AND RISK OF THE PATIENT ACQUIRING AN INFECTION. THERE WAS NO ALLEGATION AGAINST THE LONGEVITY OF THE PACEMAKER. THIS LEAD WAS SURGICALLY ABANDONED.

    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 85 YR Required Intervention 4457| 4471| S404| 4088| 4087| 1294