Model Number 37800 |
Device Problem
Unintended Collision (1429)
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Patient Problems
Nausea (1970); Twitching (2172); Discomfort (2330); Complaint, Ill-Defined (2331)
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Event Date 10/05/2019 |
Event Type
malfunction
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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 their impedances were at 527 ohms.The patient was fairly certain they got a virus, which may have been what caused the nausea/stomach issues.On (b)(6) 2019, the patient reported it was determined that the fall did not affect the stimulator.Their nausea persisted, but the tenderness and twitching resolved.
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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 patient with an implantable neurostimulator (ins) for the treatment of gastrointestinal/pelvic floor.It was reported that the patient¿s dog pulled them down and dragged them on their stomach about 5 feet on (b)(6) 2019.By (b)(6) 2019 they had terrible nausea and were sick to the stomach.The patient stated it could have been due to something else.The nausea was severe for 2 days and did not go away.The abdomen felt kind of tender around the ins.The patient stated they can feel that it is there and they had not felt it before.They felt occasional twitching.They stated they are pretty thin and the device is prominent on them but it did not look obviously out of place.The patient mentioned they saw the doctor a month ago and everything was fine.No further patient complications were reported as a result of this event.
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Search Alerts/Recalls
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