Upon receipt, the pacemaker was interrogated and the memory content was analyzed indicating no anomalies.The battery status was found to be eri.The header of the device was analyzed.The set screws could be easily screwed in and out.Rests of coagulated blood were found inside the header bores.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.There was no indication of a device malfunction.An additional long-term pacing test was initiated.During the test, each pacing pulse was recorded.The evaluation of these pacing pulses documented regular device behavior.There was no intermittent or permanent loss of output.In conclusion, the device is fully functional.The analysis did not show any deviations from the technical specifications.The analysis did not reveal any sign of a material or manufacturing problem.Biotronik monitors the post-market performance of its products sensitively in order to identify any trends that may reveal over time a potential manufacturing or design issue.The historic performance of the product involved in the current case does not at this point reveal any such trend.For this reason we encourage close dialogue between clinicians and our product experts in order to explore all options to minimize any such occurrences in future.
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