Model Number 302-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Neck Pain (2433); Fibrosis (3167)
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Event Date 08/26/2015 |
Event Type
Injury
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Event Description
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It was reported the patient feels pain upon sneezing.The patient's vns settings were decreased which decreased the pain; however, the surgeon is still planning a lead replacement as he feels the pain may be related to fibrosis along the lead as the pain is positional no surgical interventions have occurred to date.Attempts for additional relevant information have been unsuccessful to date.
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Event Description
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An implant card was received by the manufacturer which showed the patient had a prophylactic generator replacement on (b)(6) 2015.The surgeon did not want to replace the lead as the impedance value was within normal limits.It was reported the patient's device was programmed back on and there was no complaint of pain.The surgeon has no plan to replace the lead and he is unsure what was causing the previously reported pain.The explanted generator was reported to be discarded at the hospital and is not expected to be returned to the manufacturer for analysis.
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Event Description
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Additional information was received that the patient was still experiencing pain, and the patient requested to have the lead replaced.The lead replacement surgery occurred on (b)(6) 2016.The device was reportedly discarded following the surgery.No additional pertinent information has been received to date.
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Event Description
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It was reported that the patient continued to experience the throat discomfort that she had experienced with the explanted lead.However, the discomfort reportedly improved with the lead replacement surgery.
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Search Alerts/Recalls
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