Model Number 37800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hernia (2240)
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Event Date 08/04/2017 |
Event Type
Injury
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient reported that they had the implant since (b)(6) 2016, and they have already had to have an incisional hernia repair already on (b)(6) 2017.They wanted to know if it was common for patients with the device to have hernia surgery.There were no further complications that have been reported as a result of this event.The indication for use was 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 from the patient reported the hernia was due to the device and was a procedure issue.The hcp was the one that discovered the issue.No further complications were reported/anticipated.
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Search Alerts/Recalls
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