MEDTRONIC NEUROMODULATION UNKNOWN EXTERNAL NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number NEU_ENS_STIMULATOR |
Device Problem
Human-Device Interface Problem (2949)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Nausea (1970); Perforation (2001); Vomiting (2144); Headache, Lumbar Puncture (2186); Malaise (2359)
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Event Date 08/02/2016 |
Event Type
Injury
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Manufacturer Narrative
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Information references the main component of the system and the other applicable components are: product id: neu_unknown_lead, serial# unknown, product type: lead.
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Event Description
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The trial patient reported there were issues during the trial lead insertion.The patient would experience a headache that would be worse when standing up.The healthcare professional had accidentally nicked the patient's spinal column and caused a cerebrospinal fluid leak.The patient was not given any sedation during the trial insert.The patient was experiencing nausea, vomiting, and was extremely ill the first 48 hours after the start of the trial and had to turn stimulation off for 1.5 to 2 days.The patient was symptom free a day after the trial ended.
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