Model Number 6172 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2020 |
Event Type
Death
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.During the processing of this incident, attempts have been made to obtain complete event information.
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Event Description
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Related manufacturer report number: 1627487-2020-47904.It was reported that the patient's health was declining after a dbs lead implant procedure.
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Manufacturer Narrative
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Date of death is unknown.
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Event Description
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Additional information received indicates that the patient had passed away on an unknown date.No further information is available at this time.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.Correction: section a date of birth should have been (b)(6), 1961 instead of (b)(6), 1961 in the initial report.This correction is reflected in this additional report 2.
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Event Description
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Additional information received indicates that the patient had a brain bleed that was detected several days after surgery, possibly after discharge.An obituary states that the patient passed away after an extended illness.
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Search Alerts/Recalls
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