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 Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  Injury  

Manufacturer Narrative

There were 57 patients that were women, 5 that were men.The average age of the patients was (b)(6) years.The mean bmi was 37 kg/m2 (range 20-67 kg/m2).This event occurred in the (b)(6), no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: world neurosurg.(2022).Https://doi.Org/10.1016/j.Wneu.2022.08.154 summary: background: insertion of cerebrospinal fluid (csf) shunts in patients with idiopathic intracranial hypertension (iih) is challenging mainly due to the small ventricles and phenotypical body habitus.In this report the authors present their surgical protocol for insertion of a ventriculoperitoneal shunt(vps) in patients with iih and the associated revision rates.Methods: the protocol comprises the following: shunt surgery by neurosurgeons with expertise in csf disorders; a frontal vps usually right sided but left sided if the left ventricle is bigger; use of the progav 2.0 valve with gravitational unit, set at 10 and the m.Scio telemetric sensor; cannulation of the ventricle with medtronic navigation system; and laparoscopic insertion of the peritoneal catheter.The authors describe the protocol and rationale and evidence behind each component and present the results of a prospective analysis on revision rates.Results: the protocol has been implemented since 1 july, 2019, and by 28 february, 2022, sixty-two patients with iih had undergone primary vps insertion.The 30-day revision rate was 6.5%, and overall 11.3% of patients underwent revision during the study period, which compares favorably with the literature.The etiology for early failures was related to the surgical technique.Conclusions: the components of the birmingham standardized iih shunt protocol are evidence based and address the technical challenges of csf diversion in patients with iih.This protocol is associated with a low revision rate, and the authors recommend standardization for csf shunting in iih.Reported events: there were sixty-two consecutive patients with iih that underwent primary shunt insertion within the first 32 months from the introduction of the birmingham standardized iih shunt protocol.There were 57 women and 5 men and at the time of surgery.The mean age was 28 years (range 16-55 years), and the mean bmi was 37 kg/m2 (range 20-67 kg/m2).There were 7 total revisions for the entire follow-up period of 33 months.None of these patients had revision between 30 days and 1 year, and none had more than 1 revision.The mean age and mean bmi of the patients who did not have revisions and ¼ those who had revisions were similar (28 vs.27 years, p 0.7; ¼ 2 37 vs.37 kg/m2, p 1).The etiology for the 4 early failures was related to surgical technique.Extraperitoneal migration of the distal tube occurred in 2 cases (both inserted via minilaparotomy), kinking of the distal tube in 1 case, and proximal underdrainage in another case.There was proximal underdrainage in one case where revision surgery as required.There was infection with propionibacterium in one case where revision surgery as required.There was overdrainage secondary to weight loss in one case where revision s urgery as required.

• 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: 15582698
• MDR Text Key: 301630566
• Report Number: 1723170-2022-01637
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 10/05/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female