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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 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 DR HE Model T180 VITALITY EL Model T127 VITALITY DR+ Model 1872 |
Voluntary Physician Advisory
FDA Classification: Class II
Accelerated life testing has confirmed that repetitive mechanical stress applied to a specific area of the titanium case can induce component damage and device malfunction only if the device is implanted subpectorally with the serial number facing the ribs (leads exiting the pulse generator in a clockwise fashion). An anterior/posterior (AP) radiograph can be used to determine device orientation. Due to component location, damage associated with this failure mode will not occur in a subcutaneous position or in a subpectoral position with the serial number facing up.
This failure mechanism can result in one or more of the following device behaviors:
Reported Events
Two (2) reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs) were received. No patient deaths related to this advisory were reported. One patient required external pacing and immediate device replacement due to lack of pacing therapy. The vast majority of affected devices are implanted subcutaneously and are not subject to this failure mechanism.
Rate of Occurrence
The implant orientation of devices is not reported. For this reason, no rate of occurrence or failure rate projection was provided. However, based on available information, it is estimated that the number of devices implanted in a susceptible orientation is likely less than 1% of the total population.
Confirmed Malfunctions (worldwide)
May 12, 2006 Population
Eleven (11) malfunctions have been confirmed from an estimated 700 devices implanted in the susceptible orientation.
January 4, 2008 Population
Six (6) malfunctions have been confirmed from an estimated 330 devices implanted in the susceptible orientation.
There have been no reported patient deaths associated with either advisory population.
Projected Rate of Occurrence
The projected rate of occurrence for the estimated 975 devices implanted in the susceptible orientation is 3% to 4% at 60 months.
Patient management recommendations for both populations remain unchanged from the May 12, 2006 physician communication.
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 Guidant office for more information. Not all products may be approved for use in all geographies, as product approval is geography specific.
