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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATAMR VALVE, SMALL SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY STRATAMR VALVE, SMALL SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number 42955
Device Problems Inaccurate Flow Rate (1249); Appropriate Term/Code Not Available (3191)
Patient Problems Fatigue (1849); Headache (1880); Seizures (2063); Vomiting (2144); Therapeutic Response, Decreased (2271); Loss of consciousness (2418)
Event Date 11/22/2016
Event Type  Injury  
Manufacturer Narrative
The returned valve was patent. Therefore the conditions of the complaint could not be duplicated by laboratory personal. The valve met the requirements for siphon, reflux, pressure-flow, and pre-implantation testing. The valve did not meet requirements for leak testing due to a tear in the top of the reservoir. It is unknown how or when this damage occurred. The instructions for use (ifu) caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, or crushing of components. ¿ the ifu also caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance. A review of the manufacturing records was not possible as no lot number was provided. All valves are 100% tested at the time of manufacture. 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.
 
Event Description
It was reported to medtronic neurosurgery that the device was implanted in (b)(6) 2016. According to the report, in late (b)(6) there was no flow through the valve and there was no grossly visible deformity or debris. The valve was replaced with a new valve that worked normally and there was no injury to the patient.
 
Manufacturer Narrative
Additional information received reported the patient had underwent 4 single shot mris prior to explant. According to the report, imaging showed an enlargement of the patient¿s ventricles. It was also stated that the patient had been kicked in the head. Device information provided. Implant date provided. A review of the manufacturing records showed no anomalies.
 
Manufacturer Narrative
Additional information received reported the patient underwent two mris while the device was implanted. The valve had also been adjusted from 2. 0 to 1. 5 on (b)(6) 2016. Reportedly, the patient was ¿acute¿ prior to having the valve revised. It was also noted the valve was primed with a solution of bacitracin and saline at implant. 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 NameSTRATAMR VALVE, SMALL
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 Key6197392
MDR Text Key63049140
Report Number2021898-2016-00481
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue Number42955
Device Lot NumberE13641
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberZ-1702-2017

Patient Treatment Data
Date Received: 12/21/2016 Patient Sequence Number: 1
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