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Model Number 9733856 |
Device Problems
Imprecision (1307); Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: other relevant device(s) are: product id: 9735585, serial/lot #: unknown, if information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a navigation system being used for a cyst fenestration procedure.It was reported that the surgeon felt inaccurate when they were in the brain.The surgeon then noticed that the articulating arm was loose.There was a path in the brain from a previous procedure that the surgeon had the passive catheter introducer aligned to, so the surgeon gently pushed on the articulating arm until navigation on the system aligned with where the surgeon was physically touching in the brain.The inaccuracy was reported to be about.5 mm.There was a less than hour surgical delay and no impact on patient outcome.
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Search Alerts/Recalls
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