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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5 SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5 SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number 25132-5
Device Problems Break (1069); Inaccurate Flow Rate (1249)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 11/21/2016
Event Type  Injury  
Manufacturer Narrative
The returned valve was patent. It met the requirements for siphon, reflux, and leak testing. However, it did not meet the requirements for pressure flow and pre-implantation testing. There was proteinaceous debris observed within the interior and exterior of the valve. Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve. The instructions for use that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system. The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris. ¿ approximately 9. 5 cm of the ventricular catheter was returned. It met the requirements for patency and leak testing. The peritoneal catheter was returned in two pieces of lengths 9 cm and 88 cm respectively. Proteinaceous debris was observed within the exterior of the catheter and the tear site appears to be jagged. It is unknown how or when this damage occurred. The returned segments were patent and passed leak testing when tested individually. The catheter met all of the requirements for the tensile strength and ultimate elongation tests. The instructions for use that accompany the device cautions that low tear strength is a characteristic of most unreinforced silicone elastomer materials, and that care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks, or tears. A review of the manufacturing records showed no anomalies. All valves are 100% tested at the time of manufacture. All catheters are 100% inspected at the time of manufacture.
 
Event Description
It was reported to medtronic neurosurgery that the device was implanted in (b)(6) 2015. According to the report, it was found that the flow through the device was poor and when checked, it was determined the peritoneal catheter was broken. Reportedly, the system was removed including the broken parts of the catheter. The system was replaced and the patient was well.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameDELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5
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
bob shokoohi
125 cremona drive
goleta, CA 93117
8055718725
MDR Report Key6199679
MDR Text Key63133385
Report Number2021898-2016-00484
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K902783
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue Number25132-5
Device Lot NumberD61262
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2014
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: 12/22/2016 Patient Sequence Number: 1
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