BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPATH

    MDR report key: 2041089 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00843
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 1, 2011
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    NHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATE. AT THIS TIME, OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    UPDATED INFORMATION: PLEASE NOTE THAT THIS LEAD IS NOT MANUFACTURED BY BOSTON SCIENTIFIC. THEREFORE, THE INITIAL REPORT WAS NOT REQUIRED TO BE SUBMITTED FROM BOSTON SCIENTIFIC.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PACER DEPENDENT PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD WAS HOSPITALIZED AFTER INTERMITTENT LOSS OF CAPTURE (LOC) ON BOTH THE LV AND RIGHT VENTRICULAR (RV) LEAD. THE LV AND RV LEAD ALSO DISPLAYED HIGH PACING THRESHOLDS. A REVISION PROCEDURE WAS PERFORMED DURING WHICH THE LV LEAD WAS TURNED OFF. ATTEMPTS TO PLACE A NEW LV LEAD WERE UNSUCCESSFUL. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPATH IMPLANTABLE LEAD NHW EXTERNAL MANUFACTURER 4047

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 0184| 4086| 4047| N119| H170| 4592| 4591| 4087| 0185| 1296