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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 Hematoma (1884); Hemorrhage, Subdural (1894); Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient's wife questioned if the device was actually working for the patient's normal pressure hydrocephalus. It was noted that the patient's wife thought the instrumentation to check the device seemed "hinky," and they were living a nightmare. It was noted they wanted to know what was wrong with the valve that caused the recall and what was done to fix it.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received stated the patient was falling down and was making no progress despite having their device. It was stated they were going to see a different neurologist.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that the patient's status was the same as before the shunt surgery. They had very good results with another manufacturer's device, but they needed a shunt revision. The patient was implanted with the manufacturer's device, and it is like they had nothing. The setting was at 0. 5. The doctor had difficulty in setting the device after surgery and could not get repeat-ability. The doctor set the device at the middle setting after surgery, but first reading showed it at 0. 5.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that the patient's husband had their shunt since (b)(6) 2019, and they couldn't stand up without falling.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that the patient's husband has had 2 subdural hematomas with their shunt from falling.
 
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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, MN 92618
9496801345
MDR Report Key8650326
MDR Text Key146380636
Report Number2021898-2019-00209
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2020
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: 05/29/2019 Patient Sequence Number: 1
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