MEDTRONIC NEUROMODULATION LEAD, UNKNOWN; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
|
Back to Search Results |
|
Model Number NEU_UNKNOWN_LEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Muscle Weakness (1967); Dysphasia (2195)
|
Event Date 06/04/2014 |
Event Type
Injury
|
Event Description
|
It was reported that the adverse event was right corona radiate infarct.It was noted that at the time of report it was unknown if the patient planned to complete deep brain stimulation (dbs) procedure.It was noted that the outcome was resolved without sequelae on (b)(6) 2014.It was noted that interventions included medical or non-surgical intervention including warfarin and phenylephrine infusion on (b)(6) 2014.It was noted that diagnostic methods included a nih stroke scale evaluation with a score of 5 and an mri without contrast showing no indications of stroke or hemorrhage on (b)(6) 2014.It was noted that and mri with contrast showed right corona radiate infarct a day later.It was noted that the etiology included surgery/anesthesia.It was noted that the event was not related to the device or therapy and was related to the implant procedure.It was noted that during lead placement the patient became sleepy, dysarthric with left facial droop and left upper extremity weakness.It was noted that the severity was severe.It was noted that the event resulted in in-patient hospitalization.It was noted that the event was a life threatening situation.Additional information was requested but was not available as of the date of this report.
|
|
Manufacturer Narrative
|
Product id: neu_unknown_ext, serial# unknown, implanted: (b)(6) 2014, product type: extension.(b)(4).
|
|
Event Description
|
Additional information received reported that the event occurred after the lead placement, but the leads were then removed once the patient started exhibiting symptoms.It was noted that the dbs had not been implanted in the patient.Additional information received reported that the site did not receive any device information.
|
|
Search Alerts/Recalls
|
|
|