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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 Device Appears to Trigger Rejection (1524)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Mosopefoluwa a. Lanlokun, emily guerriero, robert m. Friedlander, merritt l. Fajt. A case series of hypersensitivity reactions to ve ntriculoperitoneal shunt material. Journal of clinical neuroscience 91 (2021). Doi: 10. 1016/j. Jocn. 2021. 06. 030 a b s t r a c t hypersensitivity reactions to ventriculoperitoneal (vp) or lumboperitoneal (lp) shunts are rare. Symptoms often resolve following shunt replacement with a silicone-free hypoallergenic shunt. We describe novel cases of allergies to both standard and hypoallergenic shunts and highlight the utility of patch testing. Patient 1, a (b)(6) female with chiari i malformation, developed diarrhea, abdominal pain, and rash along the lp shunt tract. Patch testing was positive. The shunt was replaced with a hypoallergenic vp shunt with symptom improvement. Five weeks later, she developed a new rash. Subsequent patch testing to the hypoallergenic shunt was positive. Patient 2, a (b)(6) female with chiari i malformation, developed pruritus along the vp shunt tract. Patch testing to the standard shunt was positive. The shunt was replaced with a hypoallergenic shunt, with symptomatic improvement. One month later, she developed neck pain, headache, and pruritis. Patch testing to the hypoallergenic shunt was positive. The development of a pruritic rash along the shunt tract with or without gastrointestinal symptoms should prompt shunt allergy evaluation and consideration of patch testing to the shunt material. Reported event. - patient 1 is a (b)(6) female with chiari i malformation and multiple drug allergies. Five months following vp shunt placement, the shunt was revised due to a shunt malfunction. After two months, it was removed due to a propionibacterium acnes infection and an lp shunt was placed. The patient then developed diarrhea, abdominal pain, and an erythematous rash along the lp shunt tract. A lumbar puncture was performed, and culture of cerebrospinal fluid was negative. Gastrointestinal evaluation included negative infectious studies, negative celiac studies, normal fecal fat and pancreatic elastase. Esophagogastroduodenoscopy with biopsies showed no villous blunting. The rash persisted despite oral steroid treatment, so she underwent patch testing to the standard lp shunt material, which was positive at 48 h. The shunt was replaced with a hypoallergenic vp shunt (medtronic, minneapolis, mn), after which she noted initial symptom resolution. Five weeks later, she developed erythema and pruritus along the new shunt tract. Subsequent patch testing to the hypoallergenic shunt was positive at 48 and 96 h. Following negative infectious workup, the vp shunt was removed and an antibiotic-impregnated frontal ventriculostomy with a manometer/external ventricular drain (evd) was placed to rule out elevated intracranial pressures in the absence of the shunt system. Patient 1 had a maximum pressure of 16 mmhg over ten days of monitoring following shunt removal. As the evd trial demonstrated that the pressure was not elevated, a new shunt was not placed in the patient. See attached literature article.
 
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Brand NameUNKNOWN VALVE/SHUNT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12393666
MDR Text Key268998326
Report Number2021898-2021-00158
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 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN-V
Device Catalogue NumberUNKNOWN-V
Device Lot NumberUNKNOWN-V
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 Received08/19/2021
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: 08/31/2021 Patient Sequence Number: 1
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