Related manufacturer reference number: 2017865-2021-18636, 2017865-2021-18638.It was reported that when a mechanical saw was being used to amputate the patient¿s leg in a procedure on (b)(6) 2019, loss of cardiac pacing was observed due to noise oversensing from the saw result in pacing inhibition.The patient was pacemaker dependent.The patient became severely bradycardia, hypertensive and went into cardiac arrest.The patient suffered injury to the brain due to anoxic encephalopathy.The patient was transferred to another facility and remained non-responsive at this facility.The patient expired on (b)(6) 2019 as a natural consequence of severe anoxic encephalopathy.
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