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

Model Number UNKNOWN-C

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2018

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 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Madoka nakajima, masakazu miyajima, chihiro akiba,md, ikuko ogino, kaito kawamura, hidenori sugano, takeshi hara, yuichi tange, keiko fusegi, kostadin karagiozov, hajime arai.Lumboperitoneal shunts for the treatment of idiopathic normal pressure hydrocephalus: a comparison of small-lumen abdominal catheters to gravitational add-on valves in a single center.Operative neurosurgery 15 (2018).Doi: 10.1093/ons/opy044 background: treating idiopathic normal pressure hydrocephalus (inph) with lumboperitoneal shunts (lpss) may cause cerebrospinal fluid (csf) overdrainage.Objective: to investigate whether lpss, including gravitational ¿add-on¿ and programmable pressure valves (ppvs/+gvs), reduce complications and improve outcomes.Methods: we compared ppvs/+small lumen abdominal catheters (sls) to ppvs/+gvs using different opening pressures for supine and standing positions.We analyzed 115 patients with inph in 2 consequent cohorts: 48 patients receiving lpss with ppvs/+sls and 67 patients receiving lpss with ppvs/+gvs.The modified rankin scale (mrs), japan inph grading scale, mini mental state examination, frontal assessment battery, and csf biomarkers were evaluated.Results: comparisons of postoperative clinical factors in 64 patients in the ppv/+sl and ppv/+gv groups using 1:1 propensity score matching revealed differences in the mean (±standard deviation) postoperative mrs (2.65 ± 1.07 vs 2.16 ± 1.02, p =.049) and gait disturbance scores (1.97 ± 1.03 vs 1.39 ± 0.92, p =.011).Thus, outcomes improved in the lps group with the gv.Serious and nonserious adverse event rates for the ppv/+sl and ppv/+gv groups were 22.9% and 19.4% (p =.647) and 38% and 17.9% (p =.018), respectively, indicating higher rates of subdural collections for the ppv/+sl group.Conclusion: this is the first study to examine lps treatment for inph using a gv in tandem with a ppv.Our results suggest that the csf shunt flow volume is restricted in the standing position and maintained in the supine position, thus improving inph symptoms.This may reduce intracranial csf hypotension-related complications.Reported events.The rates of shunt tube migration requiring revision in the ppv/+sl and ppv/+gv groups were 4.1% (n = 2/48) and 1.5% (n=1/67), respectively (p =.375).The rates of shunt tube rupture requiring revision in the ppv/+sl and ppv/+gv groups were 0% (n = 0/48) and 1.5% (n=1/67), respectively (p =.395).The rates of shunt tube obstruction requiring revision in the ppv/+sl and ppv/+gv groups were 7.8% (n = 4/48) and 13.4% (n=9/67), respectively (p =.394).

• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8189903
• MDR Text Key: 131175601
• Report Number: 2021898-2018-00585
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 12/04/2018
• 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: 75 YR