Model Number S0521-02 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Hemorrhage, Subarachnoid (1893)
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Event Type
Death
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Manufacturer Narrative
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Product evaluation: analysis results not available; device not returned for evaluation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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During a communication in june 2016 between a medtronic international medical affairs staff member and the performing surgeon, additional information regarding patient outcome was obtained.It was reported to sophono that a patient who was already using an implant successfully on the right side since (b)(6) 2013, elected to receive an additional implant on the left side in (b)(6) 2014.The surgeon reported that both procedures were routine cases performed under general anesthesia.Approximately 15 - 20 minutes after surgery for the second implant, when the patient was in the recovery room, he started to complain of a headache, collapsed and lost consciousness.The patient was intubated and a ct scan confirmed a large intracranial bleed (sub-arachnoid hematoma) on the left side.The patient was then transferred to a neurosurgical hdu unit at another facility, still unresponsive.The additional information received in june of 2016 indicated that the patient ultimately expired.The performing surgeon confirmed there was no allegation against the device.Multiple attempts have been made to obtain additional information regarding this event.No further information is available at this time.
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Manufacturer Narrative
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Date of this report: 03/16/2016.Date manufacturer received: 01/05/2017.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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