Model Number 9734887 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Excessive Heating (4030)
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Patient Problem
Burn(s) (1757)
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Event Date 04/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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Unique device identifier (udi) is unavailable.No parts have been received by the manufacturer for evaluation.Device manufacture date is unavailable.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 that, while in a imri cranial resection procedure, the patient experienced a burn underneath the non-invasive patient tracker when they exited the magnetic resonance imaging (mri).There was no reported delay to the procedure due to this issue.
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Manufacturer Narrative
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The tracker has been returned for analysis.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: device manufacture date provided.(b)(4), a supplemental report will be issued.
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Manufacturer Narrative
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The tracker was returned for analysis.Functional testing found that the tracker was functioning as designed.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 that, while in a imri cranial resection procedure, the patient experienced a burn underneath the non-invasive patient tracker when they exited the magnetic resonance imaging (mri).There was no reported delay to the procedure due to this issue.As part of the investigation related to ri-243515342, medtronic received additional information that the site staff indicated they used a surgical staple gun with stainless steel staples to affix the tracker to the patient¿s scalp prior to the mri scan.Due to the surgical setup of the procedure, the length of cable between the tracker and the cable bundle was approximately 11 inches (28 cm), and the cable bundle was placed on the side of the patient¿s shoulder.The patient burn was directly under the tracker approximately the size of a quarter.There was white area in the center with redness and no blistering or bleeding.There was no odor from the burn or smoke seen during the scan, although the patient had covering over their head and was isolated in the mri suite.There was no immediate pain noted as the patient was under general anesthesia.There was no damage noticed to the device.Additional complaint information was received from the manufacturer of the mr imaging system (ge healthcare) which contained the following additional details: ¿ mr system operation was normal and ready for patient scanning.¿ follow up with a mr manager at the site identified two workflow related errors that may have contributed to this event: patient was scanned with a length of cable between the tracker and the cable bundle of greater than 20 cm.The customer also noted that they did not use the ge recommended rf padding during the procedure.¿ the mr manager at the site reported that the patient was diagnosed with a 2.0 cm by 2.0 cm superficial burn on the scalp which was located directly underneath the point of contact between the patient's scalp and the medtronic tracker.The customer reported that the burn was treated with silvadene dressing.
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Manufacturer Narrative
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Correction:"unique device identifier (udi) is unavailable." inadvertently included in initial mdr submission.Value that was populated is valid.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Correction: patient age updated.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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