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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 02/23/2011
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 complications of the nlg were 3 cases of distal malposition of the catheter requiring a revision (in 2 cases the cat heter was placed in the subcutaneous tissue and in one case in the submuscular layer) and 1 case of intraoperative bowel perforation occurred requiring the assistance of a general surgeon. - the short-term complication of the nlg was 1 patient requiring surgical revision of the proximal catheter.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9764115
MDR Text Key191665807
Report Number2021898-2020-00069
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? 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 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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