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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 Problem Insufficient Information (3190)
Patient Problems Headache (1880); Swelling (2091); Tinnitus (2103); Visual Impairment (2138)
Event Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Badih j. Daou, ahmad sweid, joshua h. Weinberg, robert m. Starke, robert c. Sergott, allison s. Doermann, julie hauge, mario zanaty, nohra chalouhi, reid gooch, nabeel herial, hekmat zarzour, pascal jabbour, robert h. Rosenwasser, stavropoula tjoumakaris. Effect of shunting on visual outcomes and headache in patients with idiopathic intracranial hypertension. World neurosurgery 142 (2020). Doi: 10. 1016/j. Wneu. 2020. 05. 186 background: visual dysfunction and headache are major symptoms in patients with idiopathic intracranial hypertension (iih). We aimed to evaluate the improvement of these symptoms in patients who underwent ventriculoperitoneal (vps) and lumboperitoneal (lps) shunting. Methods: electronic medical records were reviewed to identify baseline and treatment characteristics for patients diagnosed with iih over 10 years. Visual outcomes and headache were evaluated at the latest follow-up post shunting. Results: we included 163 patients with a mean age of 32. 6 years. Most patients (74. 2%) underwent vps versus 25. 8% of patients who received lps. After a mean follow-up duration of 35 months, there was a 58. 3% decrease in patients reporting headache (p
=
0. 006), an 87. 7% decrease in papilledema (p
=
0. 1), a 100% resolution of diplopia with vps or lps, and an 88. 5% decrease in transient visual obscurations (p
=
1). In the worse eye, improved visual acuity (va) occurred in 53. 7% of eyes (p
=
1), was stable in 16. 4%, and worsened in 29. 8%. The mean logmar va was improved by 0. 06 logmar (20/68) in the worse eye (p
=
0. 97) and 0. 08 logmar (20/31) in the better eye (p
=
0. 7). The visual function that impairs daily activity was decreased by 55. 4% (p
=
0. 08). Patients shunted within 1 month of presentation had a significantly higher rate of headache (p
=
0. 04) and va improvement (p < 0. 001). Conclusions: vps and lps are effective in improving visual symptoms and headache in patients with iih. Reported events. - 35 patients still experienced headaches after shunting. - 8 patients still experienced papilledema after shunting. - 5 patients still experienced transient visual obscurations after shunting. - 4 patients still experienced tinnitus after shunting. - 10 patients still experienced relative afferent pupillary defect after shunting. 40 out of the 121 patients were implanted with a vps from the manufacturer; however, it was unknown how many were affected with the reported events.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10630528
MDR Text Key214800217
Report Number2021898-2020-00259
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 10/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2020
Is this an Adverse Event Report? No
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 Received10/01/2020
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

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