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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-S
Device Problems Disconnection (1171); Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Migration (4003)
Patient Problems Hematoma (1884); Hemorrhage, Subdural (1894); Unspecified Infection (1930); Complaint, Ill-Defined (2331)
Event Date 09/26/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Tsung-hsi yang, cheng-siu chang, wen-wei sung and jung-tung liu. Lumboperitoneal shunt: a new modified surgical technique and a comparison of the complications with ventriculoperitoneal shunt in a single center. Medicina 55 (2019). Doi:10. 3390/medicina55100643. Abstract: background and objectives: hydrocephalus remains a disease requiring surgical treatment even in the modern era. Ventriculo peritoneal (vp) shunt placement is the most common treatment, whereas lumboperitoneal (lp) shunts are less commonly used due to initial reports of very high rates of complications. In the present study, we retrospectively reviewed our experience of the new two-stage procedure with lp shunt implantation to assess the complications and the results of this procedure versus vp shunt insertion. Materials and methods: all patients from a single center who had received lp shunts using a medtronic strata device or vp shunts in the past six-year interval were retrospectively reviewed. The lp shunt insertion was a new two-stage procedure. We compared the three major complications and shunt revisions between the two groups, including shunt malfunction, infection, and subdural hematoma. Results: after matching the age and sex of both groups, we included 96 surgery numbers of lp shunts and 192 surgery numbers of vp shunts for comparison. In the lp shunt group, one patient (1. 0%) underwent revision of the shunt due to shunt infection. In the vp shunt group, 26 surgeries (13. 5%) needed revision, and 11 surgeries (5. 7%) had shunt infection. Shunt malfunction occurred in 14 patients (7. 3%) and all needed revisions. The revision rate showed statistically significant dierences between the lp and vp shunt groups (p <(><<)> 0. 001). Conclusions: the recent improvements in the quality of the lp shunt device and the proficiency of the procedure has made the lp shunt a safer procedure than the vp shunt. The programmable valve can avoid overdrainage complications and reduce the revision rate. With our procedural steps, the lp shunt can be used to decrease the complications and revision rates. Reported events. - in the lp shunt group, one patient (1. 0%) underwent revision of the lp shunt due to shunt infection. One patient (1. 0%) experienced chronic subdural hematoma and subdural effusion due to overshunting after adjustment of the valve to a lower pressure. In this case, the symptoms were improved by adjusting the strata valve to a higher pressure, and a second operation was not necessary. - in the vp shunt group, 26 surgeries (13. 5%) needed revision. Of these, 11 (5. 7%) surgeries had shunt infection (7 patients need revisions once and 2 patients underwent two revisions). Shunt malfunction which included obstruction, disconnection, dislocation, and migration, occurred in 14 patients (7. 3%) and all needed revisions. Subdural hematoma occured in 5 patients (2. 6%) and one patient needed revision.
 
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Brand NameUNKNOWN STRATA VALVE/SHUNT
Type of DeviceSHUNT, 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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key9298119
MDR Text Key167366483
Report Number2021898-2019-00402
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeTW
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 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
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 Received11/06/2019
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: 11/08/2019 Patient Sequence Number: 1
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