MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number S7 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Tissue Damage (2104); Injury (2348); Iatrogenic Source (2498)
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Event Date 02/18/2016 |
Event Type
Injury
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Manufacturer Narrative
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The site declined to provide patient information, per (b)(6) privacy laws.Head frame is biocompatible - material intended for patient contact.On 03/08/2016 a medtronic representative, following-up at the site, was told the patient did require medical treatment for the bulla, however, details of treatment was unknown.No further details were provided.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.
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Event Description
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A medtronic representative received a report from a site that that navigation with a navigation system was used for otorhinolaryngology surgery.After the procedure was completed, it was noted the patient had bulla on the forehead where head frame was attached.Tegaderm was put on the forehead of the patient and a seal was put on the tegaderm.The head frame was put on the seal and fixed with the use of headband.The site medical engineer is asking the medtronic representative if there is an action that can be taken as precaution to avoid bulla.There was no delay of therapy.The surgeon completed the procedure with the use of the navigation system.
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Manufacturer Narrative
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Correction: this event should have been reported as an adverse event only and not a product problem.A medtronic representative, following up with the site, reported that the tegaderm (non-medtronic product) was attached to the patient's forehead directly.This event was reviewed by a cross-function engineering team and found: the instructions for use, which accompanies the head frame device contains warnings and contraindications for use of the head frame and head frame adhesive.However, the head frame adhesive was not applied to the patient's forehead and therefore was not the cause of the adverse event.
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