BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 4132234 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14151
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    February 4, 2010
    Report Date
    September 22, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, RIGHT VENTRICULAR PACING, AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXHIBITING AN INCREASE IN RIGHT VENTRICULAR (RV) LEAD PACE IMPEDANCE MEASUREMENTS. THE PATIENT WAS TO BE BROUGHT IN FOR TROUBLESHOOTING. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. SUBSEQUENT INFORMATION INDICATES THAT IMPEDANCE MEASUREMENTS HAVE NOT INCREASED OUT OF RANGE AT THIS TIME. THE LEAD WAS FUNCTIONING FINE AT THE PATIENT'S FOLLOW-UP APPOINTMENT. THERE WERE NO OTHER COMPLICATIONS REPORTING. TECHNICAL SERVICES (TS) DISCUSSED CONTINUING TO MONITOR THE PATIENT AND IMPEDANCE MEASUREMENTS AT THIS TIME. ADDITIONAL INFORMATION INDICATES THAT THE PACING IMPEDANCES HAVE NOW INCREASED TO 1,773 OHMS AND THE PACING THRESHOLDS HAVE INCREASED TO 1.8 VOLTS AT 1 MILLISECOND. THE SHOCK IMPEDANCES ARE STABLE ALONG WITH SENSING. THERE IS NO NOISE ON THE ELECTROGRAM. THE PHYSICIAN HAS ELECTED TO PERFORM DEFIBRILLATION THRESHOLD (DFT) TESTING. AT THIS TIME, NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. YEARS LATER IT WAS REPORTED THAT THE IMPEDANCE ROSE OUT OF RANGE AT GREATER THAN 2,000 OHMS AND THAT THE RV PACING OUTPUTS WERE HIGH. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE RV LEAD WAS SURGICALLY CAPPED AND ABANDONED AND THIS ICD WAS EXPLANTED AND REPLACED. THERE WERE NO VISIBLE ABNORMALITIES NOTED ON THE LEAD THROUGH FLUOROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612114 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R 4086| 0184| T167