BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2041557 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01091
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS NOTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW-UP FOR APPROXIMATELY THREE YEARS. LOW AND HIGH IMPEDANCES WERE NOTED, AS WELL AS NOISE. IT WAS REPORTED THAT THE PATIENT HAD SEVERAL DIVERTED EPISODES, WHICH HAD OVERWRITTEN WHAT THE PATIENT REPORTED TO BE FIVE TO SIX SHOCKS IN THE RECENT PAST. THE DEVICE WAS PROGRAMMED TO TURN TACHYCARDIA THERAPY OFF FOR AN UNRELATED SURGERY. THE PATIENT WILL BE MONITORED AT THE HOSPITAL UNTIL THE SURGERY, AT WHICH TIME THE DEVICE AND/OR LEAD WILL ALSO BE REVISED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT IMPEDANCES WERE BOTH GREATER THAN 3,000 OHMS AND LESS THAN 200 OHMS. THE NOISE WAS ONLY ON THE RV CHANNEL, AND DID NOT RESULT IN ANY PACING INHIBITION FOR THE PATIENT. A LEAD FRACTURE WAS ALLEGED. A REVISION PROCEDURE WAS SUBSEQUENTLY PERFORMED, DURING WHICH THE SYSTEM WAS EXPLANTED TO UPGRADE THE PATIENT TO A DUAL CHAMBER SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention T135| 0185