MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number NEU_INS_STIMULATOR |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Hemorrhage, Cerebral (1889); Dysphasia (2195); Complaint, Ill-Defined (2331)
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Event Date 01/26/2015 |
Event Type
Injury
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Event Description
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It was reported that after the lead was implanted the patient had "temporary parenthesis" and speech arrest.The patient¿s healthcare professional (hcp) decided to remove the electrode and take a trans-operative ct scan.The ct scan showed that the patient suffered an intraparenchymal hemorrhage.At the time of this report the patient was in the intensive care unit.The patient already had a deep brain stimulation system and they were having the lead revised.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.
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Manufacturer Narrative
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Concomitant medical products: product id: 3387-40, serial# unknown, product type: lead.(b)(4).
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Search Alerts/Recalls
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