Model Number 3116 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Nausea (1970); Pain (1994); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Burning Sensation (2146); Hernia (2240); Complaint, Ill-Defined (2331); Abdominal Distention (2601)
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Event Type
Injury
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Manufacturer Narrative
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The main component of the system and other applicable components are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.
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Event Description
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The healthcare provider (hcp) reported via the manufacturer representative (rep) that the patient came to the hcp's office the week prior to the report and wanted their device removed.They didn't really give a good reason, just that it wasn't working.It was indicated that the patient had nausea, vomiting, bloating, severe burning, and a feeling that it was being ripped out of their body.The patient saw another hcp yesterday, and that hcp did not want to remove the device.They felt there was too much danger of full thickness damage of the stomach wall.The patient was scheduled to see the hcp on (b)(6) 2017 to assess removal.Additional information received stated that the patient saw the hcp on (b)(6) 2017.They were going to schedule to have the device removed sometime in (b)(6) 2017.The issue was not resolved.There were no further complications reported as a result of this event.The indication for use was gastrointestinal/pelvic floor and gastric stimulation.
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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 reported the patient's device was removed on the day of the report.The leads were adhered to the stomach wall and that may have caused some of the pain.The patient also felt that they were allergic to the device.They said they were allergic to all metal except gold.No further complications were reported/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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