|
Model Number SPM-35 |
Device Problems
Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
|
Patient Problems
Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Anemia (1706); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Emotional Changes (1831); Fever (1858); Fistula (1862); Foreign Body Reaction (1868); Granuloma (1876); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Scar Tissue (2060); Seroma (2069); Tachycardia (2095); Urinary Retention (2119); Vomiting (2144); Hernia (2240); Impaired Healing (2378); Ascites (2596); Fibrosis (3167); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hernia.It was reported that after implant, the patient experienced product failed, infection, capsule of mesh, hernia recurrence, abdominal pain, mental/physical pain, inflammation, bowel necrosis, fistula, extensive bowel adhesions, bowel deserosalization, bowel erosion, enterotomy, suffering, disability, impairment, and loss of enjoyment of life.Post-operative patient treatment included multiple attempts at mesh removal surgery, spleen removal, treatment for infection, bowel resection, and removal mesh.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced product failed, infection, capsule of mesh, hernia recurrence, abdominal pain, mental/physical pain, inflammation, bowel necrosis, fistula, extensive bowel adhesions, bowel deserosalization, bowel erosion, enterotomy, suffering, disability, impairment, loss of enjoyment of life, diverticulitis, fluid collection, wound abscess, seroma, fibrous capsule, abnormal levels of white blood count; hemoglobin; platelets; phosphorus; hematocrit, fibroadipose tissue, bacterial infection, wound infection, vomiting, fever, open wound, purulent drainage, chronic scar tissue, hemorrhage, nausea, tachycardia, hypotension, decreased urine output, anemia, blood clotting, acute urinary retention, oliguria, delayed return of bowel function, suture granulomas.Post-operative patient treatment included multiple attempts at mesh removal surgery, spleen removal, treatment for infection, bowel resection, mesh removal, ct scan, exploratory laparotomy, hospitalization, antibiotics, wound vac, local debridement, picc line, iv antibiotics, use of jp drain, iv fluid boluses, blood clot evacuation, repair of blood vessel with suture, blood transfusion, iv pain medication, iv fluids.
|
|
Manufacturer Narrative
|
Additional info: a1, a2, a3, a4, a5b, b2, b5, b6, b7, d3 (mfr name, street 1, mfr city, mfr region, country code, postal code), h6 (patient codes, device codes, ime e2402: diverticulitis, abnormal levels of white blood count; hemoglobin; platelets; phosphorus; hematocrit, fibroadipose tissue, decreased urine output, oliguria, delayed return of bowel function).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
|
|
Search Alerts/Recalls
|
|
|