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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage, Subdural (1894)
Event Date 07/13/2018
Event Type  Injury  
Manufacturer Narrative
Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided. Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided. Please note that this date is based off the date of publication of the article as the actual event date was not provided. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Adam tucker,md, ma, yoshinaga kajimoto, md, phd, tomohisa ohmura, md, naokado ikeda,md, phd, motomasa furuse,md, phd, naosuke nonoguchi,md, phd, shinji kawabata,md, phd, toshihiko kuroiwa,md, phd. Fluoroscopic-guided paramedian approach for lumbar catheter placement in cerebrospinal fluid shunting: assessment of safety and accuracy. Operative neurosurgery 16 (2019). Doi: 10. 1093/ons/opy176 background: spinal catheter insertion in lumboperitoneal (lp) shunt surgery for idiopathic normal pressure hydrocephalus (inph) is f requently associated with technical difficulties especially in patients with obesity and elderly patients with vertebral deformities. Objective: to elucidate the accuracy and safety of image-guided spinal catheter placement using a paramedian approach (pma). Methods: we retrospectively analyzed 39 consecutive inph patients treated by lp shunting with spinal catheter insertion via the pma. The success rate of catheter placement and the number of changes in puncture location were evaluated. Accuracy of catheter insertion was assessed by measuring both vertical and horizontal deviations in the point of catheter dural penetration from the center of the interlaminar space. Results: the success rate of catheter placement was 100% (39/39). The difficulty rate for catheter insertion, measured by the number of changes in puncture location, was 2. 6% (1/39). No bloody punctures or surgical infections were observed. Accuracy of catheter insertion, measured as the degree of deviation,was 0. 5±1. 9mm horizontally and 0. 0±2. 4 mm vertically. The rates of minor complications, including caudal catheter insertion, transient low-pressure headache, and root pain, were 5. 1% (2/39), 10. 4% (4/39), and 0% (0/43), respectively. Subdural hematoma requiring surgical intervention occurred in 1 case (2. 6%). During the mean follow-up period of 36 mo, spinal catheter rupture at the level of the spinous processes was not observed. Conclusion: fluoroscopic-guided sp inal catheter placement via the pma was safe, accurate, and reliable, even for use in geriatric and obese patients. Reported events. 5. Postoperative chronic subdural hematoma requiring operation occurred in one case. There was no concurrent administration of anticoagulation medication. However, in this case there was a delay in performing the postoperative head ct, and findings at the time of the ct showed a significant subdural fluid collection. Despite valve adjustments, burr-hole drainage treatment was performed. Following the burr-hole drainage procedure, the chronic subdural hematoma completely resolved, with subsequent successful inph therapy. Of the 41 patients in this literature article, 6 of the patients were identified to have the manufacturer's device, but it is unclear whether the reported events were involved with the 6 patients that had the manufacturer's device.
 
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Brand NameUNKNOWN CATHETER
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 55432
7635260594
MDR Report Key8593222
MDR Text Key144532510
Report Number2021898-2019-00178
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 05/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN-C
Device Catalogue NumberUNKNOWN-C
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2019
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: 05/08/2019 Patient Sequence Number: 1
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