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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-V
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Therapeutic Response, Decreased (2271); Cognitive Changes (2551)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Michael kim, ilya rybkin, harrison smith, jared cooper, michael tobias. Bone overgrowth causing proximal ventriculoperitoneal shunt malfunction. World neurosurgery 121 (2019). Doi: 10. 1016/j. Wneu. 2018. 10. 030 background: hydrocephalus is an international disease process that is commonly treated surgically with a ventriculoperitoneal shunt. This device may be prone to malfunction, most commonly from obstruction, disconnection, or infection. Case description: a (b)(6) year-old female with hydrocephalus and a ventriculoperitoneal shunt presented with altered mental status and imaging concerning for a shunt malfunction. Intraoperatively, she was found to have bone growing over and compressing the proximal occluder of the shunt valve, causing a mechanical obstruction. Removal of the bone allowed for egress of cerebrospinal fluid and return of proper shunt function. The patient did well postoperatively. Conclusion: hydrocephalus, ventriculoperitoneal shunts, and shunt revisions represent a significant health burden and cost. Here we present an unusual cause of a shunt malfunction caused by bony overgrowth. Reported events. 1. The patient is a (b)(6) year-old female with a medical history of cerebral palsy, mental retardation, seizures, and congenital hydroc ephalus requiring a vps placed at birth who presented to the emergency department from her group home with altered mental status. She had been less participatory in group activities over the previous week and had decreased oral intake. She had no nausea or lethargy. This personality change prompted cranial imaging, first with a computed tomography (ct) scan of the head, which revealed increased dilatation of her ventricles, concerning for a vps malfunction. The shunt reservoir was then tapped, revealing sluggish proximal flow with a low opening pressure and good distal flow. Given her worsening neurologic examination and ct results, she was taken to the operating room for exploration of her vps. Upon exposure of the shunt valve, bony overgrowth was immediately evident over the proximal catheter and the proximal occluder of the low pressure valve (medtronic, minneapolis, minnesota). The shunt was once again tapped with similar results as before. The distal catheter was disconnected from the valve. It was noted to flush easily, confirming its patency. However, no flow of csf was noted from the valve. As the bone over the proximal occluder was removed, csf began to sluggishly egress from the valve. The valve was then replaced. The patient did well postoperatively, and a repeat ct scan of the head showed an interval reduction in the size of the ventricles.
 
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Brand NameUNKNOWN VALVE/SHUNT
Type of DeviceSHUNT, 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 Key8188403
MDR Text Key131140077
Report Number2021898-2018-00578
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-V
Device Catalogue NumberUNKNOWN-V
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2018 Patient Sequence Number: 1
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