Model Number SC-1110-02 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); No Code Available (3191)
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Event Date 06/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Explant date: 2019 (month and date are unknown).Additional suspect medical device components involved: model #: sc-8216-70, serial #: (b)(4), description: artisan lead 70 cm.
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Event Description
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It was reported that the patent had their scs system explanted 1 year ago due to a stroke and the need for an mri.The patient's pain has improved since the stroke.It is unknown if the device caused the stroke or not.No further information can be obtained.
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Manufacturer Narrative
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Update to fields h6 for result and conclusion codes.H6 patient code 3191: no code available was used because there is not an equivalent fda code for surgical intervention.
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Event Description
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It was reported that the patent had their scs system explanted 1 year ago due to a stroke and the need for an mri.The patient's pain has improved since the stroke.It is unknown if the device caused the stroke or not.No further information can be obtained.
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Search Alerts/Recalls
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