MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37603 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Seizures (2063); Injury (2348)
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Event Type
Injury
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Event Description
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It was reported that the patient had had seizure on two separate occasions post deep brain stimulator implant.Prior to the deep brain stimulator surgery the patient had never had a history of seizures.The first seizure had occurred on (b)(6) 2014 and the patient was taken to the hospital after the seizure where a computerized axial tomography scan (cat) was performed and nothing was found.The second seizure event occurred on (b)(6); the patient had a seizure and was taken to the hospital.While the patient was in the emergency room, she had another seizure when she had gotten up to walk to the restroom.The patient had smashed her face and broke her leg which had resulted in hospitalization and surgery on the leg.The patient was in physical therapy for two weeks.The patient is now on anti-seizure medication, keppra-anti which is an epileptic drug.It was noted that since the patient had started the drug she had not had another seizure.All seizure events had occurred while the deep brain stimulator was off, the patient had never been turned on.(b)(6) 2014 was the first time, the patient had stimulation turned on.The patient had unilateral implant on the left side for a right side tremor.Following programming on the date of this report there was no visible tremor and the deep brain stimulator was working fine.There was good tremor control.The patient was scheduled for a follow up appointment in two weeks from the date of this report.
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Manufacturer Narrative
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Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3387s-40, lot# va0jfw2, implanted: (b)(6) 2014, product type: lead.(b)(4).
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