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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY DELTA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-A
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2022
Event Type  Injury  
Manufacturer Narrative
Patient information was unavailable from the site. Initial reporter and facility information was not available at the time of reporting. No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a strata device. It was reported that the patient had a strata 2 shunt that had been changing settings on it's own. Fast forward a few years and a few shunt revisions. The patient now has a delta fixed valve that was giving the patient issues. They had it initially placed in (b)(6) of 2020. It was revised last year because neuro-ophthalmology felt it was resting on the optic tract causing vision loss in my peripheral. The patient ended up having to go back in last november because the catheter had tethered. The patient is going back to the doctor on february 28th for another revision due to tethering. The neurologist is thinking that there may be some component in the shunt material that the patient is allergic to.
 
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Brand NameDELTA®
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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13663576
MDR Text Key289747288
Report Number2021898-2022-00066
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K902783
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberUNKNOWN-A
Device Catalogue NumberUNKNOWN-A
Was Device Available for Evaluation? No
Date Manufacturer Received02/16/2022
Was Device Evaluated by Manufacturer? No
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: 03/03/2022 Patient Sequence Number: 1
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