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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 Dysphagia/ Odynophagia (1815); Fall (1848); Hematoma (1884); Hemorrhage, Subdural (1894); Incontinence (1928); Seizures (2063); Encephalitis (2429); Ambulation Difficulties (2544)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient underwent ventriculoperitioneal (vp) shunt surgery in (b)(6) 2018 for normal pressure hydrocephalus. It was stated that the shunt was malfunction during follow-up visits. Last year, the patient fell from a convulsion and developed bilateral subdural hematoma. The patient underwent bilateral mini craniotomy. Incidentally, the patient developed auto immune encephalitis for which they were on immunotherapy and steroids. The neurosurgeon was now saying to undergo revision vp shunt surgery or do daily correction of pressure by the adjustment system. Additional information received reported that the patient was deteriorating further. It was stated they were not able to walk or get up, bedridden, lost bladder control, not able to spit, and difficulty in swallowing. A lumber puncture was performed, and symptoms improved dramatically. It was noted they had tested twice in the last 10 days. The doctors concluded that the vp shunt was malfunctioning, and the patient was having a revision on (b)(6) 2020.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key10043417
MDR Text Key190602564
Report Number2021898-2020-00138
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2020
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

Patient Treatment Data
Date Received: 05/11/2020 Patient Sequence Number: 1
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