Model Number 37800 |
Device Problems
Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927)
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Patient Problems
Pain (1994); Paresis (1998); Abdominal Distention (2601)
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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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Information was received from a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported the patient had terrible gastroparesis and was getting a percutaneous g tube replaced the hcp thought the patient got feeding tubes.The hcp read from the medical record, the j tube placed for gastroporesis was now status post pacemaker had significant gastrodistension which she was unable to alleviate and caused pain.The patient was seeking a g tube placement for vent.The hcp stated the patient wanted to have the g tube placed because it was lower risk.There were no further complications that have been reported as a result of this event.
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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 from the healthcare professional (hcp) reported the actions taken to resolve the significant gastro distention and pain were the pace maker was interrogation and she in touch with the surgeon and would see her on (b)(6) 2019.There were no further complications that have been reported as a result of this event.
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Search Alerts/Recalls
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