Model Number 3116 |
Device Problems
Energy Output Problem (1431); Impedance Problem (2950); Insufficient Information (3190)
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Patient Problems
Dyspnea (1816); Pyrosis/Heartburn (1883); Nausea (1970); Vomiting (2144); Complaint, Ill-Defined (2331)
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Event Date 06/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is an approximation.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 was experiencing more heartburn, acid reflux, vomiting, and got heartburn at night when they went to bed.These were noted to be sudden changes.They went to the healthcare professional¿s (hcp) office on the morning of the report to check the device and were told that the battery needed to be replaced and 1-2 leads were not within impedance tolerance.The hcp turned the therapy off, which took the patient¿s breath away.The patient needed to find a physician to perform the surgery.No 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 received from a consumer (con).It was reported that the patient found a surgeon who would handle the surgery.For 2-3 months prior to the report, the patient noticed that they were nauseated in the mornings again.They also had heartburn and their acid reflux returned, noting that they took 40 mg of prilosec daily.The patient had an appointment scheduled with the surgeon for (b)(6), when they'll fix the battery and leads.The patient noted that the device was not on and there was no date set for a surgery.
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Search Alerts/Recalls
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