Model Number 103 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Seizures (2063)
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Event Date 03/01/2016 |
Event Type
Injury
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Event Description
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On (b)(6) 2016 it was reported that the patient has been having "multiple breakthrough seizures" and the physician is considering implanting him with a model 106 generator as he thinks it may help with the patient's seizures, though it was noted that this would be considered a prophylactic replacement.
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Event Description
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On (b)(6) 2016 it was reported that the patient was scheduled for prophylactic generator replacement on (b)(6) 2016.The clinical reason is that his seizures have increased in number and severity with the current generator.The surgeon has noted heart rate variability in this patient and suggested this new generator model as the "next step".The patient underwent the generator replacement on (b)(6) 2016.The lead impedance for the new implant was ok, 1618ohms.The explanted generator cannot be returned for product analysis per the hospital.
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Event Description
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The surgeon stated that the increase in seizures and increase in severity of the seizures were not related to vns.They were believed to be due to the patient¿s medicine, drug regimen, and disease progression.
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Search Alerts/Recalls
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