BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2153618 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06581
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 8, 2011
    Report Date
    July 27, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. THE AVAILABLE INFORMATION SUGGESTS THIS LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    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 PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR PACING LEAD PRESENTED WITH SHORTNESS OF BREATH, FATIGUE, AND WEAKNESS. PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS WERE OBSERVED AND R-WAVE MEASUREMENTS WERE UNABLE TO BE OBTAINED. IT WAS ALSO REPORTED THAT LOSS OF CAPTURE WAS OBSERVED IN UNIPOLAR AND BIPOLAR. A LEAD REVISION PROCEDURE WAS PLANNED FOR A FUTURE DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECENTLY RECEIVED FROM A PHYSICIAN'S OFFICE THAT THIS LEAD WAS NO LONGER IN SERVICE. THE OFFICE WAS CONTACTED, AND IT WAS DETERMINED A PROCEDURE TOOK PLACE 3 DAYS AFTER THIS INITIAL LEAD ALLEGATION TO ADDRESS THE ISSUE. DURING THE PROCEDURE, THIS RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO THE ONGOING LEAD ISSUE. THE PHYSICIAN ELECTED TO REPLACE THE DEVICE AS IT WAS NEAR ELECTIVE REPLACEMENT INDICATOR (ERI), AND A NEW COMPETITOR PACING SYSTEM WAS IMPLANTED ON THE OTHER SIDE OF THE BODY. NO ADVERSE PATIENT EFFECTS OTHER THAN THE ADDITIONAL PROCEDURE 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 88 YR Hospitalization| L| R 4469| 1296| 4087