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

Model Number UNKNOWN-C

Device Problems Inaccurate Flow Rate (1249); Occlusion Within Device (1423)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

This event was identified during review of scientific literature.The article contained only limited and non-specific device information.The event reported in the source literature could not be matched to information previously reported to medtronic neurosurgery.

Event Description

Joona tervonen, ville leinonen, juha e.Jaaskelainen, susanna koponen, terhi j.Huttunen.Rate and risk factors for shunt revision in pediatric patients with hydrocephalus-a population-based study.World neurosurgery 101 (2017).Doi: 10.1016/j.Wneu.2017.02.030 background: ventriculoperitoneal shunt (vps) is a common treatment for patients with hydrocephalus (hc).Vps is associated with complications that may lead to shunt revisions.We studied the surgical outcome of pediatric patients with hc in a population-based setting.Methods: the medical charts and imaging findings of 80 patients £16 years old who required vps secondary to hc were studied.Results: mean age at time of initial shunt placement was 3.2 years (sd 4.5) and mean follow-up time was 3.3 years (sd 2.9); 57% of patients were male.Half of patients underwent shunt revision with mean time to first revision of 8 months.Patients £6 months old had a higher shunt revision rate compared with patients >6 months old (p <(><<)> 0.001).The most common causes of hc requiring vps were tumors (27.5%), congenital defects (22.5%), and intraventricular hemorrhage (19%).Revision rates in the intraventricular hemorrhage and congenital defects groups were 67% (p [ 0.017) and 72% (p [ 0.016) compared with 32% in the tumor group.Programmable valves (56%) were more common than nonprogrammable valves, but there was no significant difference in shunt survival (p [ 0.632).The mean biparietal measurement change between preoperative and postoperative images was d0.9 mm in the no revision group and d6.6 mm in the revision group (p [ 0.003).Conclusions: half of patients with shunts required revision.Age £6 months and intraventricular hemorrhage and congenital defects etiologies of hc were associated with increased risk for shunt revision.Most revisions were done during the first year after the initial vps.Reported events: 7 patients required first revisions after primary shunt operation due to ventricular catheter obstruction and underdrainage.Two patients required first revisions after primary shunt operation due to peritioneal catheter obstruction and underdrainage.Four patients required first revisions after primary shunt operation due to ventricular catheter malposition and underdrainage.Two patients required first revisions after primary shunt operation due to peritioneal catheter malposition and underdrainage.See attached literature article.

• 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: 6980952
• MDR Text Key: 90396421
• Report Number: 2021898-2017-00544
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• 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: 10/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 2 YR
• Patient Weight: 3