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

Model Number UNKNOWN-A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Seizures (2063); Swelling (2091); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Cognitive Changes (2551); Lethargy (2560)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Michael s.Golinko, danielle n.Atwood, eylem ocal.Surgical management of craniosynostosis in the setting of a ventricular shunt: a case series and treatment algorithm.Childs nervous system 34 (2018).Doi: 10.1007/s00381-017-3648-y abstract purpose cerebrospinal fluid diversion via ventricular shunt is a common treatment for hydrocephalus.Change in cranial morphology associated with a sutural fusion has been termed shunt-related or induced craniosynostosis (src) or craniocerebral disproportion (ccd).We present a series of patients with src who underwent cranial vault remodeling (cvr) and our treatment algorithm.Methods thirteen patients were retrospectively reviewed who had src and cvr; 92%of patients had a ventriculoperitoneal (vp) shunt placed for largely intraventricular hemorrhage of prematurity (69% of patients) at a mean age of 2.2 months.The shunt revision rate was 38.4%, and 54% of patients had a programmable shunt placed initially.Results the mean age at time of cvr was 3.6 years old.The most commonly affected sutures (ct confirmed) were the sagittal and coronal sutures, with three patients exhibiting pan craniosynostosis.The mean time from placement of the shunt to ct evidence of sutural fusion was 2.0 years.Abnormal head shape was noted in all 13 patients; 11 of these also had either chronic headaches, papilledema, seizures, or behavioral changes in the setting of functional shunt.Mean follow-up after the initial cvr was 3.3 years.No shunt infections were attributed to the cvr.The families of all patients were contacted and reported improvement in head shape with 60% of families reporting improvement in behavior, 75% reported improvement in headaches, and 40% reported decrease in seizure frequency or intensity.Shunt setting or type was not routinely changed after cvr.Conclusions our threshold for cvr in src is met when shunt malfunction has been ruled out and there are (1) radiographic evidence of craniosynostosis, (2) signs of increased icp clinically or radiographically, and (3) cranial dysmorphism, i.E., dolichocephaly.The majority of cases of src result in improved cranial morphology in addition to some abatement of the symptoms of increased intracranial pressure.Early involvement of an experienced craniofacial/neurosurgical team could allow for early diagnosis and intervention which may prevent progression to more severe deformities.Src is a complex entity, with multiple etiologies, and a future study is needed.Reported events.A male who was implanted for intraventricular hemorrhage (ivh) had three revisions starting 1 year after cvr due to distal shunt malfunction and noted to have significant peritoneal adhesions.The shunt was eventually changed to a ventriculoatrial shunt.Originally, he had a non programmable valve, and this was changed to a programmable shunt set at 1.0 per surgeon¿s preference.The patient had been experiencing the following adverse symptoms associated to the setting of the functional shunt: abnormal head shape, headaches, and seizures.A male who was implanted for schizencephaly/ absence of corpus callosum (cc) underwent revision (before cvr) approximately 1 year after initial placement for lethargy and dilated ventricles and found to have proximal shunt malfunction.The patient had been experiencing the following adverse symptoms associated to the setting of the functional shunt: abnormal head shape, behavioral changes, headaches, and papilledema.

Manufacturer Narrative

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

Event Description

Additional information received reported that there was no further information because these were patients who did not receive a medtronic shunt for the surgery described in the literature article.It is unclear the involvement of the medtronic devices since in the literature article, the patients had medtronic devices.

• Brand Name: UNKNOWN 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7325072
• MDR Text Key: 101952876
• Report Number: 2021898-2018-00128
• 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: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-A
• Device Catalogue Number: UNKNOWN-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2018
• 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