BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2911487 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16128
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 13, 2012
    Report Date
    December 21, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILDUP OF INTERNAL BATTERY IMPEDANCE. THE DEVICE MEASURED LEAD IMPEDANCES NORMALLY. THE OBSERVATION OF EXTENDED CHARGE-TIMES IN MID-LIFE CAUSING ERI WAS CONFIRMED. THE OBSERVATION RELATED TO LOW, OOR, RV PACING IMPEDANCES WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO EXTENDED CHARGETIMES IN MID-LIFE. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND ANOTHER ICD WAS IMPLANTED. AT THE SAME TIME, THE PATIENT'S CHRONIC RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO LOW OUT-OF-RANGE PACING IMPEDANCES AND MUSCLE STIMULATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE FIELD REPRESENTATIVE REPORTED THAT THIS ICD WAS SENT TO THE HOSPITAL LAB FOR CULTURES PER PHYSICIAN ORDER, AND THE FIELD REPRESENTATIVE WILL REQUEST THAT THE HOSPITAL RETURN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18553 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R T135| 0184