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

Model Number UNKNOWN-S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Edema (1820); Fatigue (1849); Weakness (2145); No Code Available (3191)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Hyun joo park, sang hyun lee, hyeon jin park, sang-hoon shin.A porencephalic cyst formation in a (b)(6) female with a functioning ventriculoperitoneal shunt: a case-based review.Child's nervous system 34 (2018).Doi: 10.1007/s00381-018-3725-x.Abstract introduction porencephalic cysts and cerebrospinal fluid (csf) edema around the intracranial shunt catheter are rare complications of ventriculoperitoneal shunt (vps) surgery.Possible mechanisms leading to a porencephalic cyst formation in a patient with a vps include taut ventricle, dysfunction of distal catheters, and irreversible damage to the brain parenchyma caused by shunt insertion, chemotherapy, or radiation.Most of the previous reports were due to shunt malfunction and treatment consisted of shunt revision or removal.Case report we present a case of porencephalic cyst formation in a (b)(6) female as a result of cerebrospinal fluid underdrainage that was promptly improved with shunt valve adjustment.Conclusions a heightened index of suspicion is required to prevent misdiagnosis of porencephalic cysts as tumors or abscesses that may lead to unnecessary surgical explorations.Further research is needed to elucidate the pathophysiological mechanism that causes a porencephalic cyst formation.Reported event.A (b)(6) female presented to the emergency department (ed) with anorexia, increased somnolence, and generalized weakness for the past 3 days.Her past medical history was significant for brainstem glioma treated with radiation therapy (total dose 5400 cgy, 30 fractions) and obstructive hydrocephalus treated with a ventriculoperitoneal shunt (vps) insertion a month ago.Neurologic exam revealed homonymous left superior quadrantanopsia and left abducens nerve palsy due to brainstem glioma.She also had right hemiparesis grade iv/v.Compared to the preoperative imaging, mri of the brain revealed a decreased extent of ventriculomegaly and a newly appeared 4.0 × 3.9 × 2.4 cm sized porencephalic cyst around the intracranial shunt catheter.The cyst was t1-hypointense, t2-hyperintense, and did not display peripheral enhancement.Diffusion restriction was not observed.The findings were consistent with a cerebrospinal fluid cyst.Her strata vps setting had been maintained at 1.0 pl during the past month.As the ventricular size was decreased compared to the postoperative computed tomography (ct) scan performed 1 month ago and postoperative mri performed 2 weeks ago, the probability of shunt malfunction was low.X-rays of the skull, chest, and abdomen displayed an intact and mobile distal shunt catheter.Under-drainage of csf was suspected, and the shunt setting was changed to 0.5 pl before discharge.At 1 month¿s follow-up, mri of the brain displayed a markedly decreased size (1.2 × 1.2 × 1.0 cm) of the porencephalic cyst and pericatheter edema.

• Brand Name: UNKNOWN STRATA 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: 7422743
• MDR Text Key: 105198753
• Report Number: 2021898-2018-00190
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/11/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 04/11/2018
• 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): Required Intervention
• Patient Age: 6 YR