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

Model Number UNKNOWN-C

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

Patient Problem Staphylococcus Aureus (2058)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

Age: 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.Gender: 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.Event date: 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

Miguel mayol, samuel estronza,ivan j.Sosa, juan a.Vigo, emil a.Pastrana.Efficacy of hydromer-coated and antibiotic-impregnated shunt systems in reducing early shunt infections in the pediatric population.Puerto rico health sciences journal 38 (2019).Objective: shunt infection is the most common complication following a cerebrospinal fluid (csf) diversion procedure with devastating consequences.This study analyzes the efficacy of different shunt systems in reducing early shunt infections in the pediatric population.Methods: retrospective case study analysis of 177 pediatric patients with hydrocephalus de novo shunted using hydromer-coated (hc) shunt systems, antibiotic-impregnated (ai) shunt systems and standard non-impregnated shunt systems was performed and compared for the incidence of shunt infection in the early postoperative period.Results: group a consisted of standard shunt systems with 63 patients, group b were hc shunt systems with 67 patients and group c consisted of 47 patients with antibiotic-impregnated shunt systems.Mean age in group a was 1.36 +/- 3.36 years mean age in group b was 2.32 +/- 4.69 years.Mean age in group c: 0.64 +/- 1.70 years.In terms of shunt infections, hc group had 4 shunt infections (6.25%), as compared to the control group, where 7 patients (10.45%) had infections.The ai group had 1 infection (2.13%).When comparing hc systems versus standard non-impregnated there were 3 shunt malfunction in group a (4.8%), 2 shunt malfunction in group b (3.3%) and 0 shunt malfunction in group c (0%).Conclusion: hydromer-coated shunt systems and antibiotic-impregnated shunt system represent a superior alternative to standard shunt systems for the reduction of shunt infection in the early post operative period.Reported events.- there were 4 (6.25%) patients with shunt infections in the hc group.The most common causative organism was staphylococcus aureus.

• Brand Name: UNKNOWN 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 ; 9496801345
• MDR Report Key: 9740329
• MDR Text Key: 190118304
• Report Number: 2021898-2020-00065
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: RQ
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 02/21/2020
• 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): Other
• Patient Age: 2 YR