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Model Number 103 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Chest Pain (1776); Dyspnea (1816); Emotional Changes (1831); Complaint, Ill-Defined (2331)
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Event Date 03/25/2014 |
Event Type
Injury
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Event Description
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It was reported that the recently implanted vns patient underwent surgery to explant her generator on (b)(6) 2014.It is unknown if the patient¿s lead was explanted during the procedure.Following vns implant surgery, the patient was experiencing dyspnea, severe personality changes, chest pain, voice hoarseness and cough.The explanting facility will not return the explanted device to the manufacturer for analysis; therefore, no analysis can be performed.
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Event Description
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Additional information received from the physician¿s office revealed that there was no indication anything was wrong with the vns device.The patient presented at the office on (b)(6) 2014 to have the device programmed on and stated that she did not like the feeling of a foreign metal object in her body.The patient had anxiety due to the presence of the device and did not have any personality changes.It did not appear that the patient had any anxiety about the device until after it was implanted.The device was programmed on as planned and the next day, the patient complained of chest pain, shortness of breath, voice alteration, and coughing.The voice alteration and coughing were due to stimulation but the chest pain and shortness of breath were anxiety related.The physician¿s office advised the patient not to have the device explanted but did not see her again until after the explant occurred.The physician¿s office did not feel that any of the events were serious in nature and removal of the device did not occur to preclude a serious injury.
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Search Alerts/Recalls
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