Model Number SC-1132 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Device Overstimulation of Tissue (1991); Patient Problem/Medical Problem (2688)
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Event Date 04/30/2018 |
Event Type
Injury
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Event Description
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A report was received that the patients remote control would not link to the ipg after a back surgery.It was also reported that the patient felt being shocked by the stimulator which was believed to be caused by a stenosis in the cervical spine.X-ray revealed that the leads had migrated.The patient will undergo a revision procedure.
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Manufacturer Narrative
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Additional information was received that there will be no further course of action at this time.
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Event Description
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A report was received that the patients remote control would not link to the ipg after a back surgery.It was also reported that the patient felt being shocked by the stimulator which was believed to be caused by a stenosis in the cervical spine.X-ray revealed that the leads had migrated.The patient will undergo a revision procedure.
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Search Alerts/Recalls
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