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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 Problem Bowel Perforation (2668)
Event Date 08/06/2018
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
Ronald j. Benveniste, samir sur. Delayed symptom progression after ventriculoperitoneal shunt placement for normal pressure hydrocephalus. Journal of neurological sciences 393 (2018), doi: 10. 1016/j. Jns. 2018. 08. 002. Abstract: normal pressure hydrocephalus (nph) is generally treated with ventriculoperitoneal shunts (vps), with improved symptoms in the majority of patients. We performed a retrospective chart review study in order to describe patterns of, and risk factors for, delayed symptom progression after initially successful vps placement. 69 consecutive patients underwent vps placement for nph, and were followed for a minimum of 12 months postoperatively. 55 patients (80%) had objective improvement in their nph symptoms after surgery. Of these, 27 patients (49%) developed delayed deterioration of at least one of their nph symptoms, at a mean of 28. 3 months postoperatively (range, 3¿77). 1 of the 27 patients was found to have shunt malfunction; 19 had specific clinical or imaging evidence of shunt function. 6/19 patients had transient improvement in their symptoms (lasting 30 days or more) after adjustment of their programmable shunt valves (32%), although symptoms in all of these patients later worsened. During a mean follow up period of 44. 4 months (range, 15¿87), 12 patients (44%) received other neurological diagnoses felt to at least partially explain their symptoms. Increased patient age was associated with likelihood of delayed symptom progression. We conclude that delayed symptom progression is common after vps placement for nph, including after initial symptom improvement; that symptom progression can often be temporarily palliated by shunt valve pressure adjustment; and that older patients are more likely to experience delayed symptom progression. We suggest that patients and their families be counselled accordingly before surgery. Reported events: 1 patient experienced a bowel injury after vp shunt placement.
 
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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 Key8015706
MDR Text Key125347726
Report Number2021898-2018-00515
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2018
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 Received10/03/2018
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: 10/29/2018 Patient Sequence Number: 1
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