MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN VENTRICLEAR II CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Fever (1858); Tachycardia (2095); Fungal Infection (2419); Neck Stiffness (2434); Increased Respiratory Rate (2486)

Event Date 10/13/2017

Event Type  Injury  

Manufacturer Narrative

Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved are provided.Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved are provided.Please note that this date is based off the date of publication of the article as the actual event date was not provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Feng shang, yueqiao xu, ning wang, weitao cheng, wenjin chen, & wanru duan.Diagnosis and treatment of severe neurosurgical patients with pyogenic ventriculitis caused by gram-negative bacteria.Neurological sciences 39(2018).Doi 10.1007/s10072-017-3146-8.Abstract: the aim of the study is to explore the experiences in diagnosis and treatment of severe neurosurgical patients with pyogenic ventriculitis caused by gram-negative bacteria (g-).Nineteen patients with pyogenic ventriculitis were reviewed for their treatment.The bacterial testing results of cerebrospinal fluid (csf), the clinical intervention, and the patients¿ prognosis were evaluated.The bacterial smears of ventricular drainage from all the cases were g- bacteria.Head ct and mri scans confirmed that they were intraventricular empyema.Eighteen cases of csf bacterial test were positive, including 12 cases of acinetobacter baumannii positive, 2 of klebsiella pneumonia positive, 2 of serratia marcescens positive, 1 of pseudomonas maltophilia positive, and 1 case of escherichia coli positive.One case of the bacterial culture was negative.All patients were treated by using intraventricular lavage in combination with intravenous and intraventricular antibiotics in accordance with the clinical conditions.After treatment for 2 to 8 weeks, 14 patients were cured (74%) and 5 were died (26%).Eight patients who were cured had received ventriculoperitoneal shunt due to hydrocephalus at 2 to 6 weeks after infection controlled, and none of them had any reinfection.Twelve of the 14 cured cases came to consciousness, but 2 were persistent in vegetative state starting before the infection; they did not show any improving consciousness after infection had been cured.Suppurative ventriculitis in severe neurosurgical patients is mainly infected by g- with a higher mortality.Early diagnosis, especially in identifying pathogen types, timely ventricular irrigation, and ventricular drainage together with intravenous and intraventricular antibiotic treatment, should improve prognosis.Reported events.All patients showed the signs of neck stiffness, fever, increased respiratory rate, and sinus tachycardia to a certain extent.A (b)(6) year old male with a primary diagnosis of sah/ivh/ahp developed apv (acute pyogenic ventriculitis) after placement of the evd (external ventricular drainage).The bacteria detected was mdr-ab (multidrug-resistant acinetobacter baumannii).Antibiotics used for treatment were mp (meropenem), a/s (ampicillin-sulbactam), and mn (minocycline) for 14 days.The patient was cured and received a vps (ventriculoperitoneal shunt).A (b)(6) year old male with a primary diagnosis of avm/ahp developed apv after placement of the evd.The bacteria detected was mdr-ab.A antibiotics used for treatment were mp, a/s, and mn for 28 days.The patient was cured and received a vps.A (b)(6) year old male with a primary diagnosis of asah/ivh/ahp developed apv after placement of the evd.The bacteria detected was mdr -ab.Antibiotics used for treatment were mp, a/s, and mn for 14 days.The patient was cured and received a vps.A (b)(6) year old male with a primary diagnosis of sah/ivh/ahp developed apv after placement of the evd.The bacteria detected was serratia marcescens.Antibiotics used for treatment were mp, a/s, and mn for 7 days.The patient was cured and received a vps.A (b)(6) year old female with a primary diagnosis of svh developed apv after placement of the evd.The bacteria detected was serratia m arescens.Antibiotics used for treatment were mp, a/s, and mn for 14 days.The patient was cured.A (b)(6) year old male with a primary diagnosis of tbi/hp developed apv after placement of the evd.The bacteria detected was k.Pneumonia to p.Maltophilia, then to candida tropicalis.Antibiotics used for treatment were mp, a/s, mn, lf (levofloxacin), and sf (sulfadiazine tablet) for 56 days.The patient was cured and received a vps.A (b)(6) year old male with a primary diagnosis of asah/ivh.Ahp developed apv after placement of the evd.The bacteria detected was mdr-ab.Antibiotics used for treatment were mp, a/s, and mn for 10 days.The patient was cured.A (b)(6) year old male with a primary diagnosis of asah/ivh.Ahp developed apv after placement of the evd.The bacteria culture was negative.Antibiotics used for treatment were mp, a/s, and mn for 5 days.The patient was cured.A (b)(6) year old female with a primary diagnosis of asah/ivh.Ahp developed apv after placement of the evd.The bacteria detected was p.Maltophilia.Antibiotics used for treatment were cf (cefoperazone sodium)+s (sulbactam)+mn, and mp + mn for 25 days.The patient was cured.

• Brand Name: UNKNOWN VENTRICLEAR II CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 9157689
• MDR Text Key: 168058144
• Report Number: 2021898-2019-00355
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-C
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR