MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number UNK_NAV_SYS

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patients in the study.Patient weight not available from the site.Event date is the online publish date of the article.Device lot number, or serial number, unavailable.510(k) is dependent upon model number and is therefore unavailable.Device manufacture date is dependent on the device lot/serial number, therefore is unavailable.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: albert m.Isaacs, chad g.Ball, nicholas sader, sandeep muram, david ben-israel, geberth urbaneja, jarred dronyk, richard holubkov, and mark g.Hamilton.Reducing the risks of proxumal and distal shunt failure in adult hydrocephalus: a shunt outcomes quality improvement study.J neurosurgery, 2021.Doi: 10.3171/2021.2.Jns202970.Abstract: objective: patient outcomes of ventriculoperitoneal (vp) shunt surgery, the mainstay treatment for hydrocephalus in adults, are poor because of high shunt failure rates.The use of neuronavigation or laparoscopy can reduce the risks of proximal or distal shunt catheter failure, respectively, but has less independent effect on overall shunt failures.No adult studies to date have combined both approaches in the setting of a shunt infection prevention protocol to reduce shunt failure.The goal of this study was to determine whether combining neuronavigation and laparoscopy with a shunt infection prevention strategy would reduce the incidence of shunt failures in adult hydrocephalic patients.Methods: adult patients (age = 18 years) undergoing vp shunt surgery at a tertiary care institution prior to (pre¿shunt outcomes [shout]) and after (post-shout) the start of a prospective continuous quality improvement (qi) study were compared.Pre-shout patients had their proximal and distal catheters placed under conventional freehand approaches.Post-shout patients had their shunts inserted with neuronavigational and laparoscopy assistance in placing the distal catheter in the perihepatic space (falciform technique).A shunt infection reduction protocol had been instituted 1.5 years prior to the start of the qi initiative.The primary outcome of interest was the incidence of shunt failure (including infection) confirmed by standardized criteria indicating shunt revision surgery.Results: there were 244 (115 pre-shout and 129 post-shout) patients observed over 7 years.With a background of shunt infection prophylaxis, combined neuronavigation and laparoscopy was associated with a reduction in overall shunt failure rates from 37% to 14%, 45% to 22%, and 51% to 29% at 1, 2, and 3 years, respectively (hr 0.44, p < 0.001).Shunt infection rates decreased from 8% in the pre-shout group to 0% in the post-shout group.There were no proximal catheter failures in the post-shout group.The 2-year rates of distal catheter failure were 42% versus 20% in the pre- and post-shout groups, respectively (p < 0.001).Conclusions: introducing a shunt infection prevention protocol, placing the proximal catheter under neuronavigation, and placing the peritoneal catheter in the perihepatic space by using the falciform technique led to decreased rates of infection, distal shunt failure, and overall shunt failure.Reported events: nine shunt failures were noted to have been caused by an infection.Four shunt failures were noted to have been caused by overdrainage of cerebrospinal fluid (csf).

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13045052
• MDR Text Key: 283745702
• Report Number: 1723170-2021-02924
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male