Model Number 37800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Nausea (1970); Sepsis (2067); Therapeutic Response, Decreased (2271)
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Event Date 01/01/2017 |
Event Type
Injury
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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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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 had been having issues like sepsis and other infections, which started in 2017.They also stated that the therapy helped, but sometimes they would want to throw up, but couldn¿t.This was a loss of therapy and had been happening since 2018.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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Event Description
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Additional information was received from the patient.It was reported that the patient had a consultation scheduled with a new physician on (b)(6) 2019 to discuss removal of the device.The patient clarified that by ¿other infections¿ they meant that they had sepsis and other blood infections.The patient was not sure if the sepsis was related to the device or therapy and mentioned that it could be, but also could be related to their other issues.It was noted that the patient had one episode of a sepsis infection prior to the device being implanted in (b)(6) 2016 and two other episodes of sepsis afterwards.The patient wanted to get testing done to resolve the loss of therapy and inability to vomit but with the restriction of not being able to get mris with the device implanted, the patient thought that this limited the testing that they could do.No other actions or interventions were taken to resolve the issues and they were not currently resolved.The patient was planning to remove the device, but the explant surgery had not been scheduled yet.No further complications were reported or anticipated.
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Search Alerts/Recalls
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