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 Problem Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided.Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Madoka nakajima, masakazu miyajima, ikuko ogino, chihiro akiba, kaito kawamura, chihiro kamohara, keiko fusegi, yoshinao harada, takeshi hara, hidenori sugano, yuichi tange, kostadin karagiozov, kensaku kasuga, takeshi ikeuchi, takahiko tokuda and hajime arai.Preoperative phosphorylated tau concentration in the cerebrospinal fluid can predict cognitive function three years after shunt surgery in patients with idiopathic normal pressure hydrocephalus.Journal of alzheimer's disease 66 (2018).Doi: 10.3233/jad-180557 abstract.Background: idiopathic normal pressure hydrocephalus (inph) is commonly treated by cerebrospinal fluid (csf) shunting.However, the long-term efficacy of shunt intervention in the presence of comorbid alzheimer¿s disease (ad) pathology is debated.Objective: to identify ad-associated csf biomarkers predictive of shunting surgery outcomes in patients with inph.Methods: preoperative levels of total and phosphorylated tau (p-tau) were measured in 40 patients with inph divided into low (<(> <<)>30 pg/ml) and high (=30 pg/ml) p-tau groups and followed up for three years after lumboperitoneal shunting.The modified rankin scale (mrs), mini-mental state examination (mmse), frontal assessment battery, and inph grading scale scores were compared between the age-adjusted low (n = 24; mean age 75.7 years [sd 5.3]) and high (n = 11; mean age 76.0 years [sd 5.6]) p-tau groups.Results: cognitive function improved early in the low p-tau group and was maintained thereafter (p = 0.005).In contrast, the high p-tau group showed a gradual decline to baseline levels by the third postoperative year (p = 0.040).Although the p-tau concentration did not correlate with the preoperative mmse score, a negative correlation appeared and strengthened during follow-up (r2 = 0.352, p <(><<)> 0.001).Furthermore, the low p-tau group showed rapid and sustained mrs grade improvement, whereas mrs performance gradually declined in the high p-tau group.Conclusions: preoperative csf p-tau concentration predicted some aspects of cognitive function after shunt intervention in patients with inph.The therapeutic effects of shunt treatment were shorter-lasting in patients with coexisting ad pathology.Reported events.In the high p-tau group, the mmse and fab scores had not improved.Further, they tended to decline to below the preoperative values after three years, although this decrease was not statistically significant.The mrs score in the high p-tau group gradually declined to below the preoperative value at three years after intervention.After three years, 8.3% of the patients in the low p-tau group and 45.5% in the high p-tau group showed decreased mrs scores.An improvement in cognitive function was observed in the early postoperative stages in both groups, but gradually declined after peaking at six months.Moreover, after three years, the cognitive inphgs items were at the same levels as pretreatment in the high p-tau group.The improvement in gait disturbance in the high p-tau group was poor and dropped below the preoperative value after three years.A gradual improvement was observed from three to six months in the high p-tau group; however, it was not statistically significant.Moreover, urinary function in the high p-tau group gradually worsened after a year.

• 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: 8185081
• MDR Text Key: 131335715
• Report Number: 2021898-2018-00574
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 11/27/2018
• Initial Date FDA Received: 12/20/2018
• 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 Age: 74 YR