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Model Number CSK-TC10 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Date 11/22/2017 |
Event Type
Death
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Manufacturer Narrative
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Expiration date: na.Additional suspect medical device components involved in the event: model # csk-tc10, lot # m403, description: csk tc electrode, 10cm.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
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Event Description
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A report was received that during a lumbar radiofrequency procedure, the patient passed away.The anesthesiologist noted there were some issues monitoring the patient¿s vital signs and the monitors were changed.By the time the new monitor was brought into the room, the patient did not have a heartbeat or pulse.The patient was flipped over and immediately intubated.The physician and the anesthesiologist do not know the reason for the patient¿s passing, however, they are under the impression that the patient had some sort of stroke or heart attack.The physician did not suspect any device malfunction pertaining to the patient's passing.
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Search Alerts/Recalls
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