BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 3211632 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08342
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 23, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A LOOSE HEADER. X-RAY ANALYSIS CONFIRMED THE FEEDTHRU WIRES WERE INTACT AND THE DEVICE PASSED TESTING VERIFYING THE PERFORMANCE OF PACING, SENSING AND SHOCKING FUNCTIONS. 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.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED PER THE PATIENT'S DISCRETION (E.G., DEVICE AT ERI, PATIENT HAS NOT REQUIRED THERAPY AND EJECTRION FRACTION WAS NORMAL). UPON REMOVAL OF THE ICD, THE HEADER BECAME DETACHED FROM THE CASING. THE FIELD REPRESENTATIVE NOTED THAT THE PHYSICIAN DID NOT FORCEFULLY TUG ON THE DEVICE, ALTHOUGH THE IMPLANT WAS SUB-MUSCULAR AND THE PATIENT IS YOUNG AND ACTIVE. THE FIELD REPRESENTATIVE ALSO NOTED SOME FORCEP SCRATCHES ON THE DEVICE CASING, ALTHOUGH THE PHYSICIAN CONFIRMED HE DID NOT USE REMARKABLE FORCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309543 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR 0184| T135