BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM 2

    MDR report key: 1954112 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24264
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    May 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR LABORATORY, INITIAL DEVICE INTERROGATION REVEALED THAT THE ICD HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND FAILED THE LONGEVITY CALCULATION. FURTHER ANALYSIS IS BEING CONDUCTED TO DETERMINE THE ROOT CAUSE FOR THESE OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS SUCCESSFULLY REPLACED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. AT THIS TIME, THERE IS NO ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) WITH A MONITORING VOLTAGE OF 2.38 VOLTS. TO DETERMINE IF THE BATTERY DEPLETED IN A NORMAL FASHION, OUR LABORATORY TECHNICIANS USED ENGINEERING FORMULAS TO CALCULATE EXPECTED LONGEVITY. BASED ON THE AVAILABLE PARAMETERS AND THERAPY HISTORY, WE DETERMINED THAT THIS DEVICE DID NOT MEET EXPECTED LONGEVITY. DETAILED TESTING OF THE ICD WAS CONDUCTED IN AN EFFORT TO DETERMINE THE CAUSE OF THE PREMATURE BATTERY DEPLETION. TESTS WERE PERFORMED, INCLUDING MECHANICAL MANIPULATION, AND TEMPERATURE TESTING. IN ADDITION, WHILE PACING AT THE MAXIMUM ATRIAL AND VENTRICULAR PACING OUTPUTS, THE DEVICE WAS MONITORED FOR AN EXTENDED PERIOD OF TIME. DURING THE MONITORING PHASE, THE DEVICE'S CURRENT REMAINED NORMAL WITH APPROPRIATE DEVICE OPERATION. THE TITANIUM CASE WAS THEN OPENED AND A DETAILED VISUAL INSPECTION OF THE INTERNAL COMPONENTS AND CIRCUITRY REVEALED NO IRREGULARITIES. THE DEVICE WAS AGAIN SUBJECTED TO EXTENDED MONITORING WHILE PROGRAMMED TO MAXIMUM PACING OUTPUTS, WITH NO ABNORMAL DEVICE OPERATION OBSERVED. DESPITE EXHAUSTIVE ANALYSIS, WE WERE UNABLE TO ASCERTAIN THE SOURCE FOR THE PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO BATTERY STATUS AT ELECTIVE REPLACEMENT INDICATOR (ERI). THERE WAS A CONCERN THAT THE BATTERY HAD DEPLETED EARLIER THAN EXPECTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1860

    Patients

    Seq Age Sex Outcome Treatment
    1