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

Model Number UNKNOWN-V

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2007

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

Paola peretta, paola ragazzi, christian f.Carlino, pierpaolo gaglini & giuseppe cinalli.The role of ommaya reservoir and endoscopic third ventriculostomy in the management of post-hemorrhagic hydrocephalus of prematurity.Child's nervous system 23 (2007).Doi 10.1007/s00381-006-0291-4.Abstract objective the aim of this study is to retrospectively evaluate a series of consecutive patients affected by posthemorrhagic hydrocephalus in prematurity, treated with an implant of an ommaya reservoir followed by ventriculoperitoneal (vp) shunt and/or endoscopic third ventriculostomy (etv) to evaluate the safety and efficacy of these treatment options in the management of the condition.Methods between 2002 and 2005, 18 consecutive premature patients affected by intra-ventricular haemorrhage (ivh) grades ii to iv, presenting with progressive ventricular dilatation, were operated for implant of an intraventricular catheter connected to a sub-cutaneous ommaya reservoir.Cerebrospinal fluid was intermittently aspirated percutaneously by the reservoir according with the clinical requirements and the echographic follow-up.The patients who presented a progression of the ventricular dilatation were finally operated for vp shunt implant or etv according with the mri findings.Results one patient had grade ii, 5 had grade iii, and 12 had grade iv i vh.The mean age at ivh diagnosis was 5.2 days; the mean age at reservoir implant was 17.3 days.The ommaya reservoir was punctured on an average basis of 11.4 times per patient (range 2¿25), and the mean interval between aspirations was 2.7 days.The mean csf volume per tap was 20 ml.One patient died for pulmonary complications during the study period.Out of the 17 survivors, 3 did not develop progressive ventricular dilatation, and their reservoir was removed; 14 developed progressive hydrocephalus, 5 of whom were implanted with a vp shunt and 9 received an etv.Amongst the five shunted patients, two were re-admitted for shunt malfunction and had their shunt removed after etv after 6.1 and 20.5 months, respectively.Amongst the nine patients who received an etv, five had to be re-operated for vp shunt implant at an average interval of 2.17 months (range 9¿172 days) because of increasing ventricular dilatation.Two of them had a redo third ventriculostomy with shunt removal at 11 and 25.1 months, respectively, after insertion.The first was reimplanted with a vp shunt 4 days later; the second remains shunt free.Therefore, at the end of the follow-up period, 10 out of 17 children affected by posthemorrhagic hydrocephalus in prematurity were shunt free (59%).Conclusions the combination of ommaya reservoir, vp shunt, and the aggressive use of etv as a primary treatment or as an alternative to shunt revision allowed for a significant reduction of shunt dependency in a traditionally shunt-dependent population.Further studies are warranted to optimise the algorithm of treatment in these patients.Reported events.Out of the five patients primarily implanted with a vp shunt, two were re-admitted with shunt malfunction.They received an etv, and their shunts were removed 6.1 and 20.5 months after the first vp shunt implant, respectively.Out of the nine patients primarily treated with etv, five presented progressive ventricular dilatation and eventually required vp shunt implant at an average interval of 2.17 months (range 9¿172 days) from the date of the etv.Two of them were readmitted with shunt malfunction and had a redo third ventriculostomy with shunt removal at 11 and 25.1 months, respectively, after insertion.The first was reimplanted with a vp shunt 4 days later; the second remained shunt free.

• 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: 8145276
• MDR Text Key: 129897887
• Report Number: 2021898-2018-00553
• 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: 12/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2018
• 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
• Date Manufacturer Received: 11/12/2018
• 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