MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN NON-DELTA VALVE/SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-B

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Therapeutic Effects, Unexpected (2099)

Event Date 11/30/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: please note that this date is based off the date of publication of the article as the actual event date was not provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Yong han & min chen & jin xu & yongqiang wang & hangzhou wang.Acquired chiari type i malformation managed by expanding posterior fossa volume and literature review.Child's nervous system (2019).Doi: 10.1007/s00381-019-04437-0.Abstract purpose the acquired chiari type i malformation is a rare late complication of supratentorial shunting in children which is often accompanied by abnormal cranial vault thickening.Several surgical treatments for this disease have been proposed including supratentorial skull enlarging procedures and subtentorial craniotomy.But there is still debate about the best treatment strategy for this disease.Method and results we reviewed the current knowledge of this disease in the paper.We illustrated one patient of symptomatic acquired chiari type i malformation who had cysto-peritoneal (c-p) shunting and ventriculoperitoneal (v-p) shunting.We observed the csf flow dynamic of this patient at different periods.The acquired chiari type i malformation disappeared on imaging after thinning the occipital planum combined with the standard surgical therapy of chiari decompression.The symptoms of the patient were relieved after surgery.Conclusion overshunting manifestations require prompt recognition and management.Preventive measures should be taken which include making a stringent selection of cases being considered for surgery, avoiding c-p drainage, and placing of a programmable valve as initial treatment of intracranial arachnoid cysts (ac) if shunting is considered.Reported event.- the patient was a (b)(6)-year-old girl with a left temporal arachnoid cyst (ac) when she was born.The surgery of c-p shunting was performed with a ps medical low valve in children¿s hospital of nanjing when she was about (b)(6) year old in 2009.The ac got smaller and disappeared eventually 5 years later after the procedure.The girl did well until 2018 when she reported the onset of episodic headaches, typically associated with an orthostatic posture.Neuroradiological investigation demonstrated smaller ventricles and an acquired chiari type i malformation.We thought this was due to excessive drainage of csf.Then, placement of a v-p csf shunting was carried out in our hospital in 2018.Valve pressure of the v-p shunting was set at 140 mm h2o.At the same time, cp shunting ligation was performed.The patient¿s headaches diminished after this surgical procedure.

• Brand Name: UNKNOWN NON-DELTA VALVE/SHUNT
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9613451
• MDR Text Key: 180370389
• Report Number: 2021898-2020-00029
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-B
• Device Catalogue Number: UNKNOWN-B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 10 YR