MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2018-02-03 for UNKNOWN NEUROPEN UNKNOWN-ES manufactured by Medtronic Neurosurgery.
[98961218]
Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided. Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided. Please note that this date is based off the date of publication of the article as the actual event date was not provided. The source literature included the following device specifics: a sterile 15-cm semi-rigid (1. 14 mm in diameter) stylet ne uroendoscope (neuropen) is inserted into a ventricular slotted innervision catheter (2. 8 mm in outer diameter) with a distal slit tip (innervision ventricular catheter). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[98961219]
Wenjun shen, hasan r. Syed, gurpreet gandhoke, roxanna garcia, tatiana pundy, tadanori tomita. Endoscopic third ventriculostomy in children with a fiber optic neuroendoscopy. Child's nervous system. Doi: 10. 1007/s00381-017-3679-4. Abstract: objective: endoscopic third ventriculostomy (etv) provides a shunt-free treatment for obstructive hydrocephalus children. With rapidly evolving technology, the semi-rigid fiber optic neuroendoscopy shows a potential application in etv by blunt fenestration. A retrospective analysis of our experience is reviewed. Methods: the authors review infants and children who underwent etv using this technique from june 2004 to june 2016 with radiological and clinical follow-up done by a single surgeon. Patients who underwent etv with channel scope were excluded. Demographic variables and operative reports were collected. Improvement of preoperative symptoms and avoidance of additional cerebrospinal fluid (csf) diversion procedures were considered a success. The etv success score (etvss) was used to correlate with clinical outcomes. Results: a total of 79 patients were included with a mean age of 8. 3? 5. 5 years, and 40. 5% were female. The mean clinical and radiographic follow-up was 38. 6? 40. 9 months. The overall complication rate was 6. 3%, while 73. 4% were considered successful. The etv failure cases received conversion to ventriculoperitoneal shunt or redo of etv with a median time of 2 months. The mean etv success score was 74. 3? 11. 8 with positive correlation between success rate (p <(><<)> 0. 05). Kaplan-meier failure-free survival rates of 30-day, 90-day, 6-month, 1-year, and 2-year were 89. 9, 83. 5, 78. 5, 75. 9, and 74. 6%. Eight patients required redo etv, and five of these patients required eventual shunt placements. Approximately 61. 9% of failure occurred within 3 months. Patients with post-intraventricular hemorrhage (ivh) /infection, and age younger than 12 months had the poorest outcome (p <(><<)> 0. 05). Conclusions: blunt dissection of the third ventricle floor under endoscopic vision with the stylet tip of a fiber optic neuroendoscopy is safe and requires less equipment in the pediatric population. This technique is successful with an optimistic long-term outcome except for infants and the post-ivh and infectious subgroups. Reported events: 8 patients required redo etv; 3 redos in 1 child and a single redo in 7 children. One patient experienced intraoperative venous hemorrhages, which required temporary external ventricular drainage (evd). Two patients experienced minor intraoperative hemorrhages without evd. 3 patients experienced post-operative staph ventriculitis. 5 out of 6 patients who experienced complications required the placement of a ventriculoperitoneal shunt eventually.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2018-00057 |
| MDR Report Key | 7239854 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-02-03 |
| Date of Report | 2018-02-03 |
| Date of Event | 2017-12-16 |
| Date Mfgr Received | 2018-01-05 |
| Date Added to Maude | 2018-02-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN NEUROPEN |
| Generic Name | ENDOSCOPE, NEUROLOGICAL |
| Product Code | GWG |
| Date Received | 2018-02-03 |
| Model Number | UNKNOWN-ES |
| Catalog Number | UNKNOWN-ES |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-02-03 |