Model Number 105 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); No Code Available (3191)
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Event Type
Injury
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Event Description
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It was reported that a patient's was having their generator replaced as the patient was having pain at his generator site that happens sporadically, lasts for 5 seconds, and makes the patient "feel funny" for about 15 seconds afterwards.Clinic notes were received and stated that "vns device is zapping patient".It was noted that the patient would feel his heart fluctuate up and down after.It was noted that the last diagnostics indicated that the device was functioning as intended.No known replacement surgery has occurred to date.No further relevant information was received to date.
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Event Description
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An implant card was received for the patient's battery replacement surgery.The surgery was indicated to be prophylactic.The device was expected for return.No device has been received to date.No additional, relevant information was received to date.
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Event Description
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Product analysis was completed for the returned generator.Visual examination of the device showed markings typical of surgical procedures.Burn marks were observed on the case, indicating potential exposure to an electrocautery tool.No other surface abnormalities were noted.All status checks were found to be within normal limits, and the generator showed no signs of variation in output signal while the device was monitored for over 24 hours in a simulated body temperature environment.The device performed according to functional specifications.No additional, relevant information was received to date.
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Event Description
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The generator was received for analysis.Analysis has not been completed to date.No additional, relevant information was received to date.
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Search Alerts/Recalls
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