BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3790182 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-07889
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THIS DEVICE PERFORMED. THIS DEVICE WAS RECEIVED WITH MULTIPLE LARGE ARC MARKS ON THE FRONT CASE. ALL SEAL PLUGS WERE INTACT AND ALL SETSCREWS MOVED FREELY. LEAD SEAL WITNESS MARKS INDICATE THAT ALL LEADS WERE FULLY INSERTED. THERE WERE TWO SHORTED LEAD INDICATORS RECORDED AFTER 31 JOULES SHOCK ATTEMPTS BASED ON DEVICE MEMORY. A 680 OHMS LOAD WAS CONNECTED TO THE RV CHANNEL AND THE MANUAL IMPEDANCE MEASUREMENT WAS 656 OHMS WHICH WAS WITHIN SPECIFICATIONS. NO ISSUE WAS FOUND WITH THE PACING IMPEDANCE MEASUREMENT CIRCUITRY - THE DEVICE PASSED BENCH TESTS. BRADY THERAPY IS STILL AVAILABLE. NO SHOCKS WERE TAKEN FROM THE DEVICE DURING ANALYSIS BECAUSE EXTERNAL ARCING TO THE CASE IS KNOWN TO CAUSE INTERNAL DAMAGE AND ADDITIONAL SHOCKS COULD CAUSE MORE DAMAGE. LABORATORY ANALYSIS COULD NOT CONFIRM THE FIELD ALLEGATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT-OF-RANGE PACING LEAD IMPEDANCE MEASUREMENT LESS THAN 200 OHMS. SUBSEQUENTLY, UPON INSPECTION OF THE LEAD DURING EXTRACTION, IT WAS DISCOVERED THAT THE LEAD CONDUCTOR HAD FRACTURED AND THE INSULATION OF THE PROXIMAL END WAS DAMAGED. ADDITIONAL INFORMATION OBTAINED INDICATES THAT THE SYSTEM WAS NOT TESTED WITH A PACING SYSTEM ANALYZER (PSA) AS THE LEAD WAS CLEARLY BROKEN. AS THE SURFACE OF THIS DEVICE WAS ALSO SLIGHTLY DISFIGURED, THIS LEAD TO THE PHYSICIAN TO DECIDE TO REPLACE BOTH COMPONENTS ON HAND. THE DEVICE WAS NOT TESTED AFTER REMOVAL AS IT WOULD HAVE REQUIRED THE USE OF A NEW LEAD FOR TESTING. THE PATIENT IS NOT PACEMAKER DEPENDENT. THE SYSTEM WAS EXPLANTED AND WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266728 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 0185| T175| F141