GUIDANT ADVISES PHYSICIANS ABOUT DEFIBRILLATOR ISSUE
Guidant is voluntarily advising physicians about lower-than-expected battery voltage regarding two cardiac defibrillators after receiving 39 reports of CONTAK RENEWAL 3 RF and RENEWAL 4 RF devices that exhibited lower than expected battery voltage prior to being implanted.
None of these devices were implanted. Engineering investigation has confirmed that the observed decline in battery voltage is related to a sustained, low-level current that can only occur during the storage/shipment stage. The company informed the FDA of the information. The agency may classify this communication action as a recall. Physicians should use this information to decide how best to treat their patients, Guidant said.
Of the approximately 4,000 RENEWAL 3 RF and RENEWAL 4 RF devices implanted to date, Guidant has received no reports of abnormal battery voltage related to this issue. Engineering investigation has confirmed that this internal low-level current may occur transiently in normal use, post implant, with negligible impact on longevity (less than two weeks over a device lifetime) and no impact on device function.
Physicians are advised to: turn off RF telemetry in the programmer (verify that RF LED indicator is off); initiate inductive interrogation and ensure that devices exhibit a BOL (beginning of life) battery voltage that is typically greater than 3.13 volts (no more than 0.1 volts below the voltage that appears on the package labeling).
Additional information is available at www.guidant.com/physician_communications/RenewalRF.pdf (http://www.guidant.com/physician_communications/RenewalRF.pdf).