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

Model Number UNKNOWN-C

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Facial Nerve Paralysis (1846); Headache (1880); Muscle Weakness (1967); Nausea (1970); Neurological Deficit/Dysfunction (1982); Weakness (2145); Weight Changes (2607); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Kaveh barami, indro chakrabarti, james silverthorn, jeremy ciporen, paul t.Akins.Diagnosis, classification, and management of fourth ventriculomegaly in adults: report of 9 cases and literature review.World neurosurgery (2018).Doi: 10.1016/j.Wneu.2018.05.073 - objective: an enlarged fourth ventricle, otherwise known as fourth ventriculomegaly (4th vm), has been reported previously in the pediatric population, yet literature on adults is scant.We report our experience with 4th vm in adults over an 11-year period and review the literature.Materials and methods: this was a retrospective chart review of adult patients with the diagnosis of 4th vm admitted to the intensive care unit in a tertiary care center.Results: nine patients were identified with 4th vm.Most presented with symptoms in the posterior fossa.Five cases were related to previous shunting and the underlying neurosurgical diseases, and average time interval to develop symptoms was 5.3 years.We divided our cases into primary, acquired, and degenerative based on the pathophysiology involved.Treatments included extended subzero cerebrospinal fluid diversion using a frontal external ventricular drain followed by low-pressure shunt revision, endoscopic third ventriculostomy, suboccipital decompression, and fourth ventricular catheter placement.Literature review identified additional published cases, and there were no reports of a formal classification scheme or treatment algorithm.Conclusions: this case series illustrates a narrow spectrum of etiologies associated with 4th vm in adults.We propose a simple classification scheme dividing 4th vm into 3 categories: primary, acquired, and degenerative.We recommend a stepwise treatment approach starting with extended subzero cerebrospinal fluid diversion followed by shunting for symptomatic primary and acquired 4th vm.Lower success rates and greater morbidity are associated with rescue procedures such as fourth ventricle drainage catheters, endoscopic third ventriculostomies, and skull base decompression.Reported events.At age 18 years, a female patient with a complicated childhood neurosurgery history transitioned from her pediatric neurosurgeon to an adult neurosurgeon with worsening upper extremity function and an enlarging cervical syrinx.At the age of 6 years, she presented with headaches, emesis, bilateral sixth nerve palsies, and communicating hydrocephalus of unknown cause.A ventriculoperitoneal shunt (vps) was placed.Two years after initial presentation, repeat neuroimaging identified small foci of subarachnoid enhancement in the posterior fossa, basal cisterns, an encapsulated lumbosacral lesion, and an enhancing thoracic tumor.She underwent subtotal resection of the lumbar tumor.The pathology was a juvenile pilocytic astrocytoma.With chemotherapy, the posterior fossa lesions decreased in size, but the midthoracic tumor enlarged.At age 10 years, she underwent subtotal resection of the thoracic tumor followed by spinal radiation and concurrent temozolomide.The tumor progressed, and she underwent a second thoracic spinal cord operation and further radiosurgery and chemotherapy.Serial neuroimaging over an 11-year follow-up period has not identified any recurrence of tumor.At her initial visit in adult neurosurgery, she reported increased headaches, nausea, anorexia, weight loss, and weakness in the arms.Mri of the brain demonstrated 4th vm and cervicomedullary crowding.It was uncertain whether her symptoms and imaging were due to 4th vm or cervicomedullary crowding.Her first adult neurosurgery operation was revision of the chiari decompression with dissection of dura off the cerebellum into the cerebellopontine spaces, bipolar treatment of the tonsils, and csf release from the foramen of magendie.Her second adult neurosurgery operation was exploration of her existing occipital and fourth ventricular shunt system with revision of the fourth ventricular catheter as the existing catheter had sluggish flow.Her headaches, chronic nausea, and upper extremity function improved.During the first month of recovery, she developed a facial nerve deficit, and the fourth ventricle catheter was replaced with a softer and shorter catheter in her third adult neurosurgery operation.She is now (b)(6) years old, and her 2-year postoperative follow-up has confirmed stable neurologic deficits and improved 4th vm on mri.

Manufacturer Narrative

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

• 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: 7674645
• MDR Text Key: 113619212
• Report Number: 2021898-2018-00327
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• 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: 08/08/2018
• 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