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

Model Number UNKNOWN-V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage, Intraventricular (1892); Complaint, Ill-Defined (2331)

Event Date 04/15/2012

Event Type  Injury  

Manufacturer Narrative

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

Jian lin, hui zhou, nu zhang, bo yin, & hang-song sheng.Effects of the implantation of ommaya reservoir in children with tuberculous meningitis hydrocephalus: a preliminary study.Child's nervous system 28 (2012).Doi 10.1007/s00381-012-1748-2.Abstract objective the role of ommaya reservoir implantation in children with tuberculous meningitis hydrocephalus (tbmh) has been seldomly reported.Therefore, we performed this study to determine the role of the ommaya reservoir in the treatment of children with tbmh.Methods we retrospectively analyzed the effects of ommaya reservoir implantation in 12 children with tbmh.Intracapsular puncture of the reservoir was performed for draining the cerebrospinal fluid and the tbm was treated by intraventricular injection of isoniazid.Results the ideal treatment outcome was observed in nine (75 %) of the 12 children; two (16.7 %) children developed serious disabilities and one of them (8.3 %) eventually died.The treatment method was effective for all six (100 %) children with palur grade ii tbm but showed no effect in three (50 %) children with grade iii and iv tbm.The number of leukocytes in the cerebrospinal fluid decreased to 20×106/l (75 %) within 2 weeks after implantation of the reservoirs.Finally, the ommaya reservoirs in eight children were removed but were retained in four children.Four children had to undergo ventriculoperitoneal shunt.Conclusion ommaya reservoir implantation has been shown to be effective in treating children with tbmh.This method may be largely suitable for children with early grade ii tbm or partly in children with grade iii tbm who have mild or moderate hydrocephalus that can alleviate after short-term treatment.Thus, a good proportion of children who undergo ommaya reservoir implantation can avoid ventriculoperitoneal shunt surgery.Reported events.1.A 6 year old female was implanted with an ommaya reservoir due to communicating tbmh.The reservoir became clogged and had to be washed with saline for proper functioning.The ommaya reservoir was not removed; however, due to the patient showing insufficient improvement in their clinical symptoms, a vp shunt surgery was performed.The patient's outcome was satisfactory.2.A 11 year old female was implanted with an ommaya reservoir due to communicating tbmh.The patient experienced an intraventricular hemorrhage after surgical removal of the reservoir but showed good recovery after conservative treatment.The patient's outcome was satisfactory.3.A 11 year old male was implanted with an ommaya reservoir due to noncommunicating tbmh.The patient showed a slight effusion around the reservoir under the scalp, which stopped after csf extraction and wound compression.The ommaya reservoir was removed, and the patient's outcome was satisfactory.

• Brand Name: UNKNOWN VALVE/SHUNT
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8123008
• MDR Text Key: 129021590
• Report Number: 2021898-2018-00543
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-V
• Device Catalogue Number: UNKNOWN-V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/01/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention