Catalog Number 9734680 |
Device Problems
Bent (1059); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/23/2014 |
Event Type
malfunction
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Event Description
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A medtronic representative reported that, while in a spine procedure, the site reported a damaged thoracic probe.No further details regarding the damage, or how it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.
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Manufacturer Narrative
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Patient information was unavailable from the site.Rma issued.No parts have been returned to manufacturer for analysis.
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Manufacturer Narrative
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The device was returned to the manufacturer for analysis and showed signs of physical damage.The tip of the device was confirmed to be twisted and bent.The reported event was confirmed.The device was replaced to resolve the issue.
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Manufacturer Narrative
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Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.
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Search Alerts/Recalls
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