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

Model Number UNKNOWN-S

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Paresis (1998); Therapeutic Effects, Unexpected (2099); Confusion/ Disorientation (2553)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Matheus fernandes de oliveira, felippe saad, rodolfo casimiro reis, josé marcus rotta, fernando campos gomes pinto.Programmable valve represents an efficient and safe tool in the treatment of idiopathic normal-pressure hydrocephalus patients.Arq neuropsiquiatr 71 (2013).Doi: 10.1590/0004-282x20130007 abstract idiopathic normal pressure hydrocephalus (inph) is characterized by gait disturbance, dementia and /or urinary incontinence, dilation of the ventricular system and normal opening cerebrospinal fluid pressure.Shunt surgery is the standard treatment of inhp.Diversions with programmable valves are recommended, once drainage pressure can be changed.However, well-defined protocols still lack guiding the steps to attain proper pressure for each patient.Methods: in our study, we reported the experience of shunting 24 patients with inph using strata® (medtronic) valve, following a protocol based on a positive tap test.Results: we observed clinical improvement in 20 patients and stability/ worsening in 4 patients.Complications occurred in five patients, including one death.The results display improvement, and complications occurred at a lower rate than reported in other studies.Conclusions: the strata® valve used in the proposed protocol represents an efficient and safe tool in the treatment of inph.- three patients did not show clinical improvement.One presented worsening of gait and dementia instead of radiological improvement (evans changed from 0.45 to 0.38); other patient presented stroke during the course of the follow-up, resulting in confusional state and hemiparesis; the only female referred worsening of gait instead of surgery.

• Brand Name: UNKNOWN STRATA 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10592764
• MDR Text Key: 208747538
• Report Number: 2021898-2020-00246
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• 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
• Date Manufacturer Received: 09/08/2020
• 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): Other