BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780163 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12511
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    January 1, 2012
    Report Date
    September 20, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    AVAILABLE EVIDENCE INDICATES THE SYSTEM REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED THAT THE PATIENT WAS SEEN FOR A REVISION PROCEDURE. THE LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LEAD WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD WAS SEEN FOR ROUTINE FOLLOW UP. UPON INTERROGATION, THE DEVICE REVEALED AN EPISODE OF NOISE FROM (B)(6) 2012. THE NOISE WAS OVERSENSED AND LED TO PACING INHIBITION WITH APPROXIMATELY TWO SECONDS OF ASYSTOLE. THE INTERROGATION ALSO REVEALED A ' CHECK RV LEAD MESSAGE. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE (FR) INDICATED THE MESSAGE WAS DETERMINED TO BE FROM A LOW, INTRINSIC R-WAVE AMPLITUDE READING. THE FR REPORTED THAT THE PATIENT WAS IN COMPLETE HEART BLOCK, THEREFORE, THERE WERE NO R WAVES TO MEASURE. SUBSEQUENTLY, A LOCAL FR INDICATED THAT THE PATIENT WOULD BE SEEN AT A LATER DATE FOR A DEVICE CHANGE OUT PROCEDURE AND AT THAT TIME, A NEW RV LEAD WOULD BE IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R H175| 0157| 4469| N118| 4512| H179