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

Model Number UNKNOWN-C

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problem Adhesion(s) (1695)

Event Date 02/23/2011

Event Type  malfunction  

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 complication of the nlg was 1 patient had a proximal malfunction of the catheter.- the short-term complication of the nlg was 1 patient had a malfunction related to the presence of a coiling in the distal catheter.- the long-term complications of the nlg were 2 proximal complications and 1 obstruction of the distal catheter to severe peritoneal adhesions.See attached literature article.

• Brand Name: UNKNOWN CATHETER
• Type of Device: SHUNT, 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 Key: 9764409
• MDR Text Key: 198536950
• Report Number: 2021898-2020-00070
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• 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 Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-C
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1