• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-S
Device Problem Complete Blockage (1094)
Patient Problems Bacterial Infection (1735); Meningitis (2389); Post Operative Wound Infection (2446)
Event Date 06/24/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Joona tervonen, hadie adams, antti lindgren, antti-pekka elomaa, olli-pekka kämäräinen, virve kärkkäinen, mikael von und zu fraunberg, jukka huttunen, timo koivisto, juha e. Jääskeläinen, ville leinonen, terhi j. Huuskonen. Shunt performance in 349 patients with hydrocephalus after aneurysmal subarachnoid hemorrhage. Acta neurochirurgica (2021). Doi: 10. 1007/s00701-021-04877-1 abstract background shunt-dependent hydrocephalus after aneurysmal subarachnoid hemorrhage (asah) is a common sequelae leading to poorer neurological outcomes and predisposing to various complications. Methods a total of 2191 consecutive patients with asah were acutely admitted to the neurointensive care at the kuopio university hospital between 1990 and 2018 from a defined population. A total of 349 (16%) asah patients received a ventriculoperitoneal shunt, 101 with an adjustable valve (2012¿2018), 232 with a fixed pressure valve (1990¿2011), and 16 a valveless shunt (2010¿2013). Clinical timelines were reconstructed from the hospital records and nationwide registries until death (n
=
120) or june 2019. Results comparing the adjustable valves vs. The fixed pressure valves vs. The valveless shunts, intraventricular hemorrhage was present in 61%, 44% and 100%, respectively. The median times to the shunt were 7 days vs. 38 days vs. 10 days. The rates of the first revision were 25% vs. 32% vs. 69%. The causes included infection in 11% vs. 7% vs. 25% and overdrainage in 1% vs. 4% vs. 31%. The valveless shunt was the only independent risk factor (hr 2. 9) for revision. After the first revision, more revisions were required in 48% vs. 52% vs. 45%. Conclusions the protocol to shunt evolved over time to favor earlier shunt. In post-asah hydrocephalus, adjustable valve shunts, without anti-siphon device, can be installed at an early phase after asah, in spite of intraventricular blood, with a modest risk (25%) of revision. Valveless shunts are not recommendable due to high risk of revisions. Reported events: - shunt revision was required in 25 (25%) of the 101 patients, until death (n
=
5) or june 2019, in a median time of 7 days since shunt insertion. The cumulative rate for the first revision was 14% at 1 month and 23% at 1 year. Of the 25 patients with shunt revision, nine had previous valve adjustments. In overall, multiple (two or more) revisions were required in 12 (48%) of the 25 revised patients. Shunt infection (n
=
11) was the most common cause for shunt revision, in a median of 5 days. All 11 patients had evd and i. V. Cefuroxime prophylaxis since the shunt installation. Ten patients had clinical meningitis, including decreased csf glucose, and one had a wound infection. However, bacterial cultures remained negative, except in two cases (staphylococcus warneri and staphylococcus aureus) considered possible contaminations. The pcr testing of csf samples was not performed. The infections somewhat clustered in the early shunts. Valve occlusion (n
=
8) was the second most common reason for shunt revision, in a median of 12 days. The 15 s hunts with the anti-siphon device were installed in a median of 39 days (iqr 8¿220), and only one of them occluded. The 86 shunts without the anti-siphon device were installed much earlier, in a median of 7 days (iqr 5¿11), and seven of them occluded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN STRATA VALVE/SHUNT
Type of DeviceSHUNT, 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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12295931
MDR Text Key266232860
Report Number2021898-2021-00146
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 08/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-S
Device Catalogue NumberUNKNOWN-S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/09/2021 Patient Sequence Number: 1
-
-