BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM

    MDR report key: 3210850 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07448
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    December 19, 2010
    Report Date
    April 24, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPETED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RECENT DEVICE EVALUATION WAS DONE AND FOUND THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) AND SUBSEQUENTLY END OF LIFE (EOL) DUE TO EXTENDED CHARGE-TIMES IN MID-LIFE. THE DEVICE WAS STILL ABLE TO DELIVER THERAPY AS THE BATTERY VOLTAGE WAS 2.55 VOLTS BUT THE CHARGE TIME WAS 32.3 SECONDS. THE PATIENT'S PREVIOUS CHECK WAS (B)(6) 2010, AND ERI AND EOL WERE DECLARED IN (B)(6) 2010 AND (B)(6) 2011 RESPECTIVELY. SURGICAL INTERVENTION WAS PERFORMED AND THE DEVICE WAS SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309171 VENTAK PRIZM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1852

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R 1852| 0185