BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3210072 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07288
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 14, 2013
    Report Date
    May 23, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABANDONED RIGHT ATRIAL (RA) LEAD WILL NOT BE RETURNED TO BOSTON SCIENTIFIC THEREFORE, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. WHILE THE DEVICE WAS RETURNED FOR ANALYSIS TO BE ANALYZED. UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A LOOSE HEADER. ALTHOUGH EVIDENCE INDICATES EXTERNAL STRESS MAY HAVE BEEN A FACTOR IN THE HEADER BECOMING LOOSE, THE CAUSE OF THE ABNORMALITY WAS ISOLATED TO INSUFFICIENT BONDING BETWEEN THE MEDICAL ADHESIVE AND THE TITANIUM CASING. MANUFACTURING ENHANCEMENTS WERE IMPLEMENTED IN 2003 TO MAKE THE BOND MORE ROBUST. THE ENHANCEMENTS HAVE DECREASED REPORTS OF THIS TYPE. THE DEVICE WAS ARCHIVED AND ANALYSIS CONCLUDED THE HEADER IS LOOSE FROM THE PULSE GENERATOR CASE.

    Additional Manufacturer Narrative · 1

    THE ABANDONED RIGHT ATRIAL (RA) LEAD WILL NOT BE RETURNED TO BOSTON SCIENTIFIC THEREFORE, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. WHILE THE DEVICE WAS RETURNED FOR ANALYSIS TO BE ANALYZED. ONCE THE PRODUCT IS RETURNED THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO NOISE AND A LEAD FRACTURE ISSUE OBSERVED DURING A RECENT DEVICE REPLACEMENT PROCEDURE. DURING THE REPLACEMENT, IT WAS OBSERVED THAT THE ADHESIVE ON THE HEADER OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SLIGHTLY SEPARATED FROM THE DEVICE. THE ATRIAL LEAD WAS THEN TESTED WITH A PACING SYSTEM ANALYZER (PSA) WHICH REVEALED THAT PACING IMPEDANCES HAVE INCREASED OVER TIME. THE DEVICE WAS EXPLANTED, REPLACED AND RETURNED FOR ANALYSIS WHILE THE LEAD WAS ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309240 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R