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 Headache (1880); Therapeutic Effects, Unexpected (2099)

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Massimiliano todisco, marta picascia, patrizia pisano, roberta zangaglia, brigida minafra, paolo vitali, elisa rognone, anna pichiec chio, roberto ceravolo, nicola vanacore, alfonso fasano, claudio pacchetti.Lumboperitoneal shunt in idiopathic normal pressure hydrocephalus: a prospective controlled study.Journal of neurology 267 (2020).Doi: 10.1007/s00415-020-09844-x abstract objective in this prospective, controlled, monocentric study, we described the clinical and neuroimaging 12-month followup of two pa rallel cohorts of subjects with idiopathic normal pressure hydrocephalus (inph), who did or did not undergo lumboperitoneal shunt (lps).Methods we recruited 78 inph patients.At baseline, subjects underwent clinical and neuropsychological assessments, 3 t magnetic resonance imaging (mri), and tap test.After baseline, 44 patients (lps group) opted for lps implantation, whereas 34 subjects (control group) declined surgery.Both cohorts were then followed up for 12 months through scheduled clinical and neuropsychological evaluations every 6 months.3 t mri was repeated at 12-month follow-up.Results gait, balance, and urinary continence improved in the lps group, without significant influence on cognitive functions.Conversely, gait and urinary continence worsened in the control group.No preoperative mri parameter was significant outcome predictor after lps.Of relevance, in responders to lps, we found postoperative reduction of periventricular white matter (pwm) hyperintensities, which were instead increased in the control group.Conclusions lps is safe and effective in inph.An early surgical treatment is desirable to prevent clinical worsening.Postsurgery decrease of pwm hyperintensities may be a useful mri marker surrogate for clinical effectiveness of lps.Reported events.- in the immediate post-surgery phase, four (9.1%) subjects complained of headache, which disappeared increasing the valve opening pressure.At the hospital discharge, the valve opening pressure was set to 1.5 (90¿110 mmh2o) in 39 and 2.0 (145¿165 mmh2o) in five patients.As a result of poor or absent improvement of motor performances within 1 month after surgery, the valve opening pressure was reduced in eight subjects, i.E.From 1.5 to 1.0 (35¿55 mmh2o) in six and from 2.0 to 1.5 in two patients.- a trend to slightly decreased effectiveness was noted in this cohort if compared to the 6-month follow-up.See attached literature article.

• 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: 10596731
• MDR Text Key: 208971190
• Report Number: 2021898-2020-00249
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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?: 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
• Date Manufacturer Received: 09/24/2020
• 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