CRM Product Performance Report Q3  2008

Product Advisory

10-Mar-07 — Product Update — Mid-life Display of Replacement Indicators

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 AVT A155 Model A155 VITALITY AVT A135 Model A135 VITALITY DS VR/DR Models T135/T125 VITALITY EL Model T127 VITALITY VR/DR Models 1871/1870 VITALITY DR+ Model 1872 ASSURE Model B301

ORIGINAL COMMUNICATION 10-Mar-07 — Product Update — Mid-life Display of Replacement Indicators

FDA Classification: Device in Column 1, Table 1 of this Product Updatewere classified as Class II (27–November-07)

Certain devices may display ERI or EOL during mid-life (typically 24–48 months), even though battery voltage (typically greater than or equal to 2.65 volts) and capacity remain available. This behavior is caused by high battery impedance rather than low battery voltage.

Devices that have triggered charge time-based ERI or EOL during mid-life have several months, and in most cases more than one year of remaining battery voltage and capacity, which allows the devices to continue to provide brady and LV pacing and maximum energy shocks. However, if ERI or EOL is triggered, device replacement should be scheduled.

Rate Projection

Certain devices, typically implanted prior to July 2005 (column 1, Table 1 of the Product Update) are projected to exhibit Mid-Life Display of Replacement Indicators as indicated below:

• VITALITY AVT (Model A135), VITALITY VR/DR, VITALITY DR+ (Projected rate: 8–10%)
• VITALITY AVT (Model A155), VITALITY DS VR/DR, VITALITY 2 VR/DR, ASSURE (Projected rate: 4–7%)
• VITALITY EL; VITALITY 2 EL DR/VR; VITALITY DR HE; CONTAK RENEWAL 3/4/3HE/4HE; CONTAK RENEWAL 3 RF/4 RF/3 RF HE/4 RF HE; CONTAK RENEWAL 3 AVT/4 AVT/3 AVT HE/ 4 AVT HE (Projected rate: 1–2%)

Continuous manufacturing improvements intended to reduce variability in battery performance have been implemented by our battery supplier, which mitigate the occurrence of mid-life display of replacement indicators.

Current Status 11-Jul-08

Confirmed Malfunctions (worldwide)

For confirmed malfunction counts related to a specific product family, refer to the Confirmed Malfunction Details section of the Product Performance Report and see pattern titled “Mid-life display of replacement indicators.”

There have been no reported patient deaths associated with this advisory.

Projected Rate of Occurrence

For projected rates of occurrence see device-specific ranges listed above.

For current performance related to a specific product family, refer to the U.S. Survival Probability section of the Product Performance Report and see population titled "10-Mar-07 — Product Update - Mid-life Display of Replacement Indicators.”

Current Recommendation 11-Jul-08

Patient management recommendations from the March 10, 2007 Product Update remain unchanged.

Patient Management Considerations

• Normal follow-up. If ERI or EOL is triggered, device replacement should be scheduled.
• Physicians can consider individual patient needs relative to the potential device behaviors associated with mid-life display of ERI or EOL.
• Activating the programmable feature “Beep When ERI is Reached” (nominally ON) will provide audible tones when the device reaches ERI.
• Last measured charge time and date are stored in device memory and are available during device interrogation. Commanding a manual capacitor reform may be helpful in characterizing the current charge time.

Standard Warranty program available, please contact your local representative for terms and conditions.