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

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.

• Brand Name: UNKNOWN VALVE/SHUNT
• Type of Device: SHUNT, 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 Key: 12393666
• MDR Text Key: 268998326
• Report Number: 2021898-2021-00158
• 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
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-V
• Device Catalogue Number: UNKNOWN-V
• Device Lot Number: UNKNOWN-V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 08/31/2021
• 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: 24 YR