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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA 2 VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY STRATA 2 VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number 42866
Device Problems Inaccurate Flow Rate (1249); Occlusion Within Device (1423); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Headache (1880); Pain (1994); Visual Disturbances (2140); Twitching (2172); Discomfort (2330); Complaint, Ill-Defined (2331); Cognitive Changes (2551)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported the shunt ¿vibrated¿ and ¿changed by itself. ¿ the valve was initially implanted at a setting of 1. 5. It in addition to the previously reported chiari malformation, the patient also had a small posterior fossa, had undergone posterior decompression ¿multiple times,¿ and had a dural patch.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported the patient was in 24-hour home care. It was stated the patient was developmentally disabled.
 
Manufacturer Narrative
The product was unavailable for return as it remains implanted. Therefore an evaluation of device performance was not possible. A review of the manufacturing records showed no anomalies. The strata valve was implanted prior to the shelf life expiration date. All valves are 100% tested at the time of manufacture. (b)(4).
 
Event Description
It was reported to medtronic neurosurgery that an implanted strata valve is past its expiration date and has become deformed inside the patient, causing harm. The report stated the alleged strata valve expiration date was (b)(6) 2012. Update 1/27/2016: upon further follow up, it was reported that a strata valve and competitor catheters were implanted on (b)(6) 2007. The report stated that the expiration date for the competitor catheters, per the patient card, was (b)(6) 2007 and the concern was that the catheters had been implanted in the same month as the catheters expiration date. According to the report the patient had chiari malformation and has had three brain surgeries. Reportedly, the patient is experiencing swelling along the shunt, pain and deterioration in hearing.
 
Manufacturer Narrative
The product was unavailable for return as it remains implanted. Therefore, an evaluation of device performance was not possible. A review of the manufacturing records showed no anomalies. The strata valve was implanted prior to the shelf life expiration date. All valves are 100% tested at the time of manufacture. Additional patient/device information: it was reported to medtronic neurosurgery that the device was clogging and not draining properly. It was also reported that shunt setting was not checked before or after the patient had an mri. The report stated that the mri caused the shunt to become warped to a pointed shape. Reportedly, the shunt is causing neck jerking in the patient. It was also reported that there is a bump on the patient's head where the shunt lies and that over time the bump has gotten more pronounced. The report also stated that the patient has surgical instability, an atypical seizure pattern, a tethered cord in the thoracic area and a slit ventricle on the right side. The patient's weight was reported as (b)(6). Additionally, it was reported that the patient had last visited their doctor's office in (b)(6) 2013 due to headaches and discomfort. According to the report, shunt evaluation at the time revealed that the shunt and ventricular system was stable. (b)(4).
 
Manufacturer Narrative
Additional information received reported the device was blocked. According to the report, it was also stated the device was overdraining at all settings since implant. Reportedly, the device had been at the 2. 0 setting since (b)(6) 2016 and a ct scan showed it was overdraining. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Correction: malfunction was inadvertently selected in the previously submitted supplemental regulatory report. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Information received reported the patient had adult encephalomalacia, ¿rare, progressive. ¿ according to the report, it started in the frontal lobe and moved to the hind brain. It was stated the patient experienced ¿ear symptoms, eye symptoms, mentation changes, pain, and photophobia. It was noted that sound caused pain and the patient was ¿very ill. ¿ manufacturer contact information updated. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTRATA 2 VALVE, REGULAR
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
stacy ruemping
7000 central avenue ne rcw215
minneapolis,mn, CA 55432
7635260594
MDR Report Key5434160
MDR Text Key116711227
Report Number2021898-2016-00061
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/30/2010
Device Catalogue Number42866
Device Lot NumberA99606
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/22/2007
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: 02/12/2016 Patient Sequence Number: 1
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