MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number UNKNOWN-E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Pietro panni, carmine antonio donofrio, lina raffaella barzaghi, lodoviga giudice, luigi albano, claudio righi, franco simionato, fr ancesco scomazzoni, silvano cozzi, maria rosa calvi, luigi beretta, andrea falini, pietro mortini.Safety and feasibility of lumbar drainage in the management of poor grade aneurysmal subarachnoid hemorrhage.Journal of clinical neuroscience 64 (2019).Doi: 10.10 16/j.Jocn.2019.04.010 a b s t r a c t the use of lumbar drain (ld) in the aneurysmal subarachnoid hemorrhage (asah) has been described to reduce cerebral vasospasm and delayed cerebral ischemia (dci), with a lack of studies referring to high grade population.The purpose of our study is to assess safety and feasibility of ld in the poor grade asah population subjected to endovascular aneurysm occlusion.Twenty-four consecutive poor grade asah patients, defined as grade iv and v according to world federation of neurological surgeons (wfns) classification, subjected to endovascular aneurysm occlusion, were retrospectively reviewed.Details of csf drainage via ld and related complications were analyzed.Ventriculo-lumbar pressure gradient (vlpg) lower than 6 mmhg was considered in order to start ld use.Good outcome was defined as modified rankin scale (mrs) 0¿2.Ld was started within 72 h since asah in 17 cases (70.8%), and in 7 cases (29.2%) it was delayed due to contraindications.The mean ld length was of 13.8 days.The median vlpg during drainage was 2 mmhg (iqr: 0¿4).No cases of brain or spinal hemorrhage, permanent neurological worsening due to brain herniation were noted.Three cases (12.5%) of csf infection and a related death (4.2%) were reported.The use of ld, in association with external ventricular drain (evd), seems to be safe and feasible in the poor grade asah population.Vlpg monitoring seems to play a key role in avoiding potentially severe complications.Reported events.- csf positive culture occurred in 1 patient and the ld catheter was substituted after antibiotic therapy start.However, the patient died due to multi-drug resistant bacterial meningo-ventriculitis.

• Brand Name: UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Type of Device: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• 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 Key: 9246689
• MDR Text Key: 164006642
• Report Number: 2021898-2019-00386
• Device Sequence Number: 1
• Product Code: GWM
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-E
• Device Catalogue Number: UNKNOWN-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2019
• 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): Death
• Patient Age: 53 YR