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

Model Number UNK_NAV_SYS

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

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994)

Event Date 08/11/2018

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient weight not available from the site.Event date is the accepted date of the publication.Device lot number, or serial number, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: m.Ege babadagli, dwaine cooke, simon a.Walling, p.Daniel mcneely endoscopic retrieval of flanged ventricular catheters.The canadian journal of neurological sciences inc.2018 can j neurol sci.2018; 45: 692-695 doi:10.1017/cjn.2018.336.Summary: abstract: flanged ventricular catheters are now used infrequently.Many patients with longstanding hydrocephalus still harbor these catheters, either as their current ventricular catheter, or as a retained catheter from a prior implant.The removal of flanged ventricular catheters is sometimes necessary, and may be challenging due to intraventricular adhesions.We describe the use of an endoscopic technique for the successful retrieval of flanged ventricular catheters in two patients.The technique described in this report may be helpful for patients that have flanged ventricular catheters that must be removed.Reported events: first patient at the age of (b)(6), presented after a period of 39 days a fever, elevated white blood cell count and an elevated c-reactive protein.Second patient at the age of (b)(6)-year-old, presented after a 3-week history of fever, chills, abdominal discomfort, and a foreign body sensation in his rectum.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10971350
• MDR Text Key: 220711067
• Report Number: 1723170-2020-03212
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050438
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• 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: 12/01/2020
• 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: 32 YR