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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-V
Device Problem Insufficient Information (3190)
Patient Problems Fever (1858); Hematoma (1884); Hemorrhage, Subdural (1894); Inflammation (1932)
Event Date 02/23/2011
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued. [(b)(4)].
 
Event Description
Soheila raysi dehcordi & claudio de tommasi & alessandro ricci & sara marzi & cristina ruscitti & gianfranco amicucci & renato j. Galzio. Laparoscopy-assisted ventriculoperitoneal shunt surgery: personal experience and review of the literature. Neurosurgical review 34 (2011). Doi 10. 1007/s10143-011-0309-6. Abstract ventriculoperitoneal shunting is a widely accepted technique for the treatment of hydrocephalus. The standard procedure to insert the peritoneal catheter requires an abdominal incision, muscle dissection, and opening of the peritoneum. A number of complications related to the abdominal surgical phase have been reported. Laparoscopy assisted ventriculoperitoneal shunting is a valid alternative procedure that reduces surgical trauma. We describe our experience and review the literature. A total of 30 laparoscopically guided ventriculoperitoneal shunting procedures were performed between january 2007 and june 2008, in collaboration with a general surgeon experienced in laparoscopy. Of these procedures, 25 were new shunt placements and 5 were revisions. Data about operative time, outcome, and complications were registered and compared with a group of 30 patients treated by means of standard laparotomy in the period 2005¿2007. Laparoscopic shunt placement was successful in all patients. Operative duration, complications, and postoperative pain were all lower in patients treated by laparoscopy as compared to the laparotomy. In the laparoscopic group, an earlier peristalsis, quicker mobilization, and better cosmetic results were also noted. Laparoscopy in both ventriculoperitoneal shunt placement and revision is a safe, effective, and minimally invasive technique. It ensures proper abdominal placement of the distal catheter under direct vision allowing confirmation of its patency. Reported events. - the immediate complication of the lg was a valve malfunction that required surgical revision. - the short-term complication of the nlg was 1 presented with a subacute subdural hematoma. The long-term complication of the lg was a valve malfunction that required a substitution. In 2 patients in the nlg, the postoperative time was characterized by fever and high values of the indices of inflammation with a negative cerebrospinal fluid culture, thus they were subjected to appropriate antibiotic treatment.
 
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Brand NameUNKNOWN VALVE/SHUNT
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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key9764607
MDR Text Key195019817
Report Number2021898-2020-00071
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeIT
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 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-V
Device Catalogue NumberUNKNOWN-V
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 Received02/07/2020
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: 02/27/2020 Patient Sequence Number: 1
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