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CONTAK RENEWAL 4 RF HE Model H239 CONTAK RENEWAL 4 RF Models H230/H235 CONTAK RENEWAL 4 HE Models H197/H199 CONTAK RENEWAL 4 Models H190/H195 CONTAK RENEWAL 4 AVT HE Models M177/M179 CONTAK RENEWAL 4 AVT Models M170/M175 CONTAK RENEWAL 3 RF HE Models H217/H219 CONTAK RENEWAL 3 RF Models H210/H215 CONTAK RENEWAL 3 HE Models H177/H179 |
CONTAK RENEWAL 3 Models H170/H175 CONTAK RENEWAL 3 AVT HE Model M159 CONTAK RENEWAL 3 AVT Model M155 VITALITY 2 EL VR/DR Models T177/T167 VITALITY 2 VR/DR Models T175/T165 VITALITY DR HE Model T180 VITALITY DS VR/DR Models T135/T125 VITALITY EL Model T127 VITALITY AVT A155 Model A155 |
Voluntary Physician Advisory
FDA Classification: Class II
Low-voltage capacitors may be subject to degradation. These capacitors may cause accelerated battery depletion and may reduce the time between Elective Replacement Indicator (ERI) and End Of Life (EOL) to less than three months. Device replacement indicators continue to function normally.
In April 2007, Boston Scientific CRM communicated with physicians regarding a population of devices subject to this failure mechanism. As of March 2009, the April 2007 advisory population has not experienced any clinically significant changes to either the rate of occurrence or patient management recommendations.
In March 2009, a second population was identified of 856 active ICDs and CRT-Ds manufactured with capacitors from the same supplier that may be subject to the same failure mechanism. The cumulative failure rate for accelerated depletion within this population is approximately 6% at 42 months and is projected to increase. Recommendations described in April 2007 have been 99.9% successful in identifying susceptible devices and ensuring replacement at ERI in the original population, and will minimize patient risk associated with a shortened replacement window when applied to this second population. No devices from this population have been registered as implanted after April 2007. No devices in this subset remain available for implant.
Confirmed Malfunctions (worldwide)
April 2007 Population
1608 malfunctions have been confirmed out of an advisory population of approximately 75,000 devices.
60 of these devices exhibited a shortened ERI to EOL replacement window (less than 90 days).
March 2009 Population
81 malfunctions have been confirmed out of an advisory population of 856 active devices.
One of those devices exhibited a shortened ERI to EOL replacement window (less than 90 days).
There have been no reported patient deaths associated with either advisory population.
No devices currently being distributed are susceptible to this malfunction mode.
Projected Rate of Occurrence
April 2007 Population
The projected rate of occurrence for the April 2007 advisory population is 3–4% at 48 months.
March 2009 Population
The cumulative failure rate for accelerated depletion for the March 2009 population is approximately 6% at 42 months and is projected to increase.
Following monitoring recommendations below will minimize patient risk associated with a shortened replacement window.
Patient management recommendations from the April 5, 2007 physician communication remain unchanged.
If a patient has a device with a degraded capacitor, the time from implant to 2.65 volts (Middle of Life 2 / MOL2) will be reduced. To determine whether a patient may be at risk for a reduced ERI to EOL time, note when 2.65 volts (MOL2) was observed. For each patient:
1. Review patient records to assess battery voltage.
2. If battery voltage is above 2.65 volts (MOL2), continue to follow patient every three months per device labeling.
3. If battery voltage is at or below 2.65 volts (MOL2), determine the time between device implant and this observation.
4. If the time from implant to 2.65 volts (MOL2) is greater than 27 months (32 months for VITALITY® EL / 2 EL / HE devices), the patient is not at risk for a shortened ERI to EOL time, and this advisory no longer applies.
5. If the time from implant to 2.65 volts (MOL2) is 27 months or less (32 months for VITALITY® EL / 2 EL / HE devices), the patient should be followed monthly until ERI. For devices that require monthly follow-up, replace the device within 30 days after ERI is displayed as ERI to EOL time may be shortened.
NOTE: If it is not clear when a battery voltage of less than 2.65 volts (MOL2) was reached, conduct a memory “Save to Disk” and return (mail or e-mail) to Boston Scientific CRM for prompt analysis. Contact your local Boston Scientific representative or Technical Services for further assistance.
In geographies where available, the LATITUDE® Patient Management System can facilitate remote patient monitoring and provide automatic notification when the device reaches a battery status of ERI.
Standard Warranty program available, please contact your local representative for terms and conditions.
With respect to the number of reported events listed in the summaries above, Boston Scientific recognizes that the actual number of clinical malfunctions may be greater than the number actually reported. Additionally, rate projections are provided with the acknowledgement that predictive modeling is inherently uncertain due to its dependence on the device age distribution of reported events and resultant statistical approximation and assumptions.
Advisory notifications may vary by geography, based upon local regulatory requirements. Please contact the local Boston Scientific office for more information. Not all products may be approved for use in all geographies, as product approval is geography specific.
