BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADENCE TIERED THERAPY DEFIBRILLATOR

    MDR report key: 171044 · Received June 5, 1998

    Report

    Report Number
    2938836-1998-00055
    Event Type
    Injury
    Date Received
    June 5, 1998
    Date of Event
    May 7, 1998
    Report Date
    May 7, 1998
    Manufacturer
    VENTRITEX, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H.3 EVALUATION SUMMARY: THE LACK OF COMMUNICATION EXPERIENCED IN THE FIELD WAS CONFIRMED AND WAS CAUSED BY LPW BATTERY VOLTAGE. AFTER THE DEVICE WAS CUT OPEN AND CONNECTED TO A POWER SUPPLY IT COMMUNICATED PROPERLY WITH A PROGRAMMER. THE IDD CURRENT FOR THE DEVICE WAS AT A TYPICAL VALUE. THERE DID APPEAR TO BE A PROBLEM WITH THE REAL-TIME ELECTROGRAMS (NO SIGNAL). IT IS BELIEVED THAT THERE IS A PROBLEM IN THE HYBRID CIRCUIT ASSEMBLY THAT CAUSED THIS ANOMALY. IT IS BELIEVED THAT THE HYBRID ISSUE MAY BE RELATED TO THE DEPLETION OF THE BATTERY.

    Description of Event or Problem · 1

    THE PT HAD NOT BEEN IN FOR A ROUTINE FOLLOW-UP IN FOUR YEARS. WHEN THE DEVICE WOULD NOT COMMUNICATE, IT WAS BELIEVED THAT IT HAD FLIPPED IN THE POCKET. UPON EXAMINATION OF THE OPENED POCKET, IT WAS POSITIONED CORRECTLY BUT WOULD STILL NOT COMMUNICATE. THE DECISION WAS MADE TO EXPLANT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADENCE TIERED THERAPY DEFIBRILLATOR Implant IMPLANTABLE CARDIAC DEFIBRILLATOR LWS VENTRITEX, INC. V-100C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other CPI L67 224857, 4320, 015630 & RX-100-TBB.