Model Number 303-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Paralysis (1997); No Code Available (3191)
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Event Date 06/26/2018 |
Event Type
Injury
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Event Description
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It was reported that the patient has recurrent paresis /vocal cord paralysis on the left side.The generator was not turned on and the device was not providing stimulation.The paresis/paralysis is suspected to be surgery related as the device had not been turned on.
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Event Description
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Product information was received.
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Event Description
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It was reported that the patient has hoarseness and recurrent palsy/paralysis.
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Event Description
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Additional information was received that the hoarseness and recurrent palsy is ongoing and is classified as severe.It is believed to be related to stimulation and implant surgery.Intervention was taken that resulted in interruption of treatment.
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Event Description
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Additional information was received that the patient's adverse event changed from hoarseness and recurrent palsy to persistent hoarseness.The persistent hoarseness was reported to be ongoing, severe, and "probably related" to implant / procedure and stimulation / device.It was reported that the patient's treatment was interrupted due to the adverse event but therapy was not discontinued.It was reported that the patient underwent speech therapy.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.
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Search Alerts/Recalls
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