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Model Number UNKNOWN-S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Cerebrospinal Fluid Leakage (1772); Pneumonia (2011); Urinary Tract Infection (2120); Respiratory Failure (2484); Convulsion/Seizure (4406)
Event Date 07/24/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event Description
Kunal p. Raygor, taemin oh, joan y. Hwang, ryan r. L. Phelps, kristen ghoussaini, patrick wong, rebecca silvers, lauren r. Ostling, and peter p. Sun. Ventriculoperitoneal shunt infection rates using a standard surgical technique, including topical and intraventricular vancomycin: the children¿s hospital oakland experience. Journal of neurosurgery pediatrics 26 (2020). Doi: 10. 3171/2020. 4. Peds209 objective ventriculoperitoneal (vp) shunt infections are common complications after shunt operations. Despite the use of intravenous antibiotics, the incidence of infections remains high. Though antibiotic-impregnated catheters (aics) are commonly used, another me thod of infection prophylaxis is the use of intraventricular (ivt) antibiotics. The authors describe their single-institution experience with a standard shunt protocol utilizing prophylactic ivt and topical vancomycin administration and report the incidenceof pediatric shunt infections. Methods three hundred two patients undergoing vp shunt procedures with ivt and topical vancomycin between 2006 and 2016 were included. Patients were excluded if their age at surgery was greater than 18 years. Shunt operations were performed at a single institution following a standard shunt protocol implementing ivt and topical vancomycin. No aics were used. Clinical data were retrospectively collected from the electronic health records. Results over the 11-year study period, 593 vp shunt operations were performed with ivt and topical vancomycin, and a total of 19 infections occurred (incidence 3. 2% per procedure). The majority of infections (n
10, 52. 6%) were caused by staphylococcus epidermidis. The median time to shunt infection was 3. 7 weeks. On multivariate analysis, the presence of a csf leak (or 31. 5 [95% ci 8. 8¿112. 6]) and age less than 6 months (or 3. 6 [95% ci 1. 2¿10. 7]) were statistically significantly associated with the development of a shunt infection. A post hoc analysis comparing infection rates after procedures that adhered to the shunt protocol and those that did not administer ivt and topical vancomycin, plus historical controls, revealed a difference in infection rates (3. 2% vs 6. 9%, p
0. 03). Conclusions the use of a standardized shunt operation technique that includes ivt and topical vancomycin is associated with a total shunt infection incidence of 3. 2% per procedure, which compares favorably with the reported rates of shunt infection in the literature. The majority of infections occurred within 2 months of surgery and the most common causative organism was s. Epidermidis. Young age (<(><<)> 6 months) at the time of surgery and the presence of a postoperative csf leak were statistically significantly associated with postoperative shunt infection on multivariate analysis. The results are hypothesis generating, and the authors propose that ivt and topical administration of vancomycin as part of a standardized shunt operation protocol may be an appropriate option for preventing pediatric shunt infections. Reported events. - there were 17 cases of postoperative csf leak, though not all of these patients required shunt revision. - 19 postoperative shunt infections occurred in cases that adhered to the study protocol with topical and ivt vancomycin. The majority (52. 6%, n
10) of shunt infections were caused by coagulase-negative s. Epidermidis. The remaining infections were caused by enterococcus faecalis and escherichia coli (n
2), e. Coli alone (n
1), proteus mirabilis (n
1), peptostreptococcus asaccharolyticus (n
1), pseudomonas aeruginosa (n
3), and a severe case of rotavirus enterocolitis (n
1). Csf cultures were positive in all patients deemed to have a shunt infection, except the patient with rotavirus enterocolitis (94. 7% culture positivity). There was one case of abdominal pseudocyst associated with s. Epidermidis csf infection. - there were 23 adverse events. Fifteen adverse events involved the development of postoperative red man syndrome (rms), though in some cases due to penicillin allergies, patients also received intravenous vancomycin, so it was not obvious whether the intravenous or ivt vancomycin was the cause in those cases. All cases of rms involved mild pruritis and were treated with intravenous diphenhydramine only. There were no cases of anaphylaxis. Two patients developed acute respiratory failure due to pneumonia in the perioperative period, requiring prolonged intubation and antibiotics, and 3 others developed urinary tract infections that required a standard antibiotic course. Two patients had postoperative seizures treated with antiepileptic medication; neither patient had a preoperative seizure history. Finally, one patient developed transient diabetes insipidus that was treated with desmopressin administration until sodium homeostasis was achieved. - 12 shunt infections were observed in which topical or ivt vancomycin was not used. See attached literature article.
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Manufacturer (Section D)
5290 california ave
irvine CA 92617
Manufacturer (Section G)
5290 california ave
irvine CA 92617
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
MDR Report Key11032912
MDR Text Key223617004
Report Number2021898-2020-00366
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN-S
Device Catalogue NumberUNKNOWN-S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/17/2020 Patient Sequence Number: 1