Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated a false alert for lead impedance out of range.Concomitant medical products: 407645 lead, implanted: (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.
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It was reported that there was a left ventricular (lv) lead low impedance warning on the device, however, when interrogated the lead trends showed no out of range impedances.The device remains in use.No patient complications have been reported as a result of this event.
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