BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DS

    MDR report key: 1042729 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33927
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 27, 2008
    Report Date
    June 24, 2010
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/55-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS PERFORMED AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THIS DEVICE HAD TWO COMPROMISED LOW-VOLTAGE CAPACITORS, WHICH RESULTED IN A HIGH CURRENT CONDITION. THIS ISSUE IS DISCUSSED IN THE Q2 2010 PRODUCT PERFORMANCE REPORT.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE WITHOUT ADDITIONAL COMPLICATION. IF ANY ADDITIONAL INFORMATION RELATED TO THIS INCIDENT BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED. THE DEVICE IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS ICD EXHIBITED A MONITORING VOLTAGE OF 2.86 V. PREMATURE BATTERY DEPLETION WAS ALLEGED. THE DEVICE BELONGS TO THE SHORTENED REPLACEMENT WINDOW (4/05/2007) ADVISORY. A TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THE POSSIBLE REMAINING LONGEVITY OF THE DEVICE AND DISCUSSED THAT IT DID APPEAR THAT THE BATTERY MAY NOT BE DEPLETING AT A NORMAL RATE. THEY RECOMMENDED PERFORMING A SAVE TO DISK; HOWEVER, THE PATIENT HAD ALREADY LEFT THE CLINIC. THE SAVE TO DISK WOULD BE PERFORMED AT THE PATIENT'S NEXT FOLLOW UP. ADDITIONAL INFORMATION WAS PROVIDED THAT THE BATTERY VOLTAGE HAD DECREASED TO 2.66 AT 29 MONTHS OF IMPLANT. THE CLINICIAN WAS NOT COMFORTABLE WITH THE BATTERY VOLTAGE AND SENT IN A SAVE TO DISK FOR FURTHER EVALUATION. A REVIEW OF THE MEMORY DISK REVEALED THAT THE DEVICE WAS NOT AFFECTED BY THE SRW ADVISORY MALFUNCTION; HOWEVER, THE DEVICE DID APPEAR TO BE DEPLETING SLIGHTLY PREMATURELY. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT LATER REPORTED HEARING BEEP TONES FROM THE DEVICE, AND THE DEVICE WAS SUBSEQUENTLY FOUND TO HAVE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE ADVISORY AND PREMATURE BATTERY DEPLETION WERE AGAIN QUESTIONED. TS DISCUSSED REPLACEMENT OF THE DEVICE. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION. ADDITIONAL INFORMATION WAS PROVIDED THAT THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY DS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other THE DEVICE 4469/457509 WAS IMPLANTED 03-JAN-2006| THE DEVICE 0184/109370 WAS IMPLANTED 03-JAN-2006