Model Number 37800 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Dyspnea (1816); Pneumonia (2011); Therapeutic Effects, Unexpected (2099); Hernia (2240); Weight Changes (2607)
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Event Date 10/25/2016 |
Event Type
Injury
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Manufacturer Narrative
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Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient weighed (b)(6) before the stimulator and weighed (b)(6) at the time of the report.They weren¿t able to lose weight and had been gaining weight since they got the stimulator.It was also reported that their hiatal hernia grew by 20% by eight months after they were implanted.They were really sick with stuff running up in their throat and caused stuff to go down into their lungs.They had to go in and get the hiatal hernia fixed because it was getting so big they could not breath.They also reported pneumonia and, when they went to the healthcare professional (hcp) for the pneumonia, they did a ct scan and found the growth of the hernia.No device issues or further complications were reported or anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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