BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY

    MDR report key: 4140496 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17028
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RV LEAD REMAINS IMPLANTED AND IN SERVICE. 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 SEVERAL DAYS AFTER THIS RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED, IT PRESENTED WITH COMPLETE LOSS OF CAPTURE AT MAXIMUM OUTPUTS. THE PATIENT DID NOT EXPERIENCE ANY ASYSTOLE OR SYNCOPE AS A RESULT OF THE LOSS OF THERAPY ON THIS RV LEAD. A REVISION PROCEDURE WAS PERFORMED. FLUOROSCOPY REVEALED NO STRESS ON THE LEAD BUT THE POSITION OF THE RV LEAD WAS CONSIDERED TO BE A BIT MORE ADVANCED INTO THE HEART TISSUE, INDICATING A LEAD PERFORATION. THE RV LEAD WAS ABLE TO BE REPOSITIONED TO A MORE SEPTAL POSITION WITH ACCEPTABLE LEAD VALUES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AN ECHOCARDIOGRAM WAS PERFORMED FOLLOWING THE REVISION AND THERE WAS NO EVIDENCE OF A PERICARDIAL EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618856 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7742

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R 7741| J277| 7742