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Model Number P101015 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Calcium Deposits/Calcification (1758); Diarrhea (1811); Vomiting (2144); Sleep Dysfunction (2517); No Code Available (3191); Constipation (3274)
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Event Type
Injury
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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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According to the reporter: mesh was placed inside the patient from a hernia operation.Since then, the patient has suffered from severe diarrhea, constipation and other stomach complications.The patient was told by a surgeon that the mesh left inside turned into calcium and now has stuck to the organs.Currently, the patient's stomach is in their chest, so the patient also suffers from insomnia because of the coughing and throwing up at night.The patient is unable to get the corrected surgery because of their health and complications from the mesh.
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Manufacturer Narrative
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Medtronic complaint report: pe:(b)(4).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Per additional information received, preoperative diagnosis: type 3 paraesophageal hernia, gastroesophageal reflux disease.Postoperative diagnosis: type 3 paraesophageal hernia, gastroesophageal reflux disease.Operation: diagnostic laparoscopy, laparoscopic repair of type 3 paraesophageal hernia, primary repair of esophageal hiatus with permacol overlay, partial gastrectomy, upper endoscopy.Post operative complaint: failed nissen fundoplication chest revealed significant pulmonary restriction.
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Search Alerts/Recalls
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