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

Model Number UNKNOWN-E

Device Problems Disconnection (1171); Malposition of Device (2616); Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); No Code Available (3191)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided.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

(b)(6).Complications of continued lumbar cerebrospinal fluid drainage for treatment of subarachnoid hemorrhage and countermeasures.China journal of modern medicine.2017, volume 27, number 16, pages 104-107.Doi: 10.3969/j.Issn.1005-8982.2017.16.023.Abstract: objective: to research the cause and countermeasure of complications of continued lumbar cerebrospinal fluid drainage (clcfd) for the treatment of subarachnoid hemorrhage (sah).Methods: the clinical data of 63 patients with sah who were hospitalized in the department of neurosurgery of our hospital from december 2014 to december 2015 were retrospectively analyzed.All of them were be treated by clcfd, and the effect and complications of clcfd were observed.Results: the time of drainage were 1-29 days with an average of (5.87 ± 1.04) days.After treatment 43 cases recovered excellently, 17 cases recovered partially, 3 cases had no improvement.There was no complication in 22 cases, 1 case had cerebral hernia, 2 cases had rebleeding, 3 cases had delayed hydrocephalus, 3 cases failed in intubation, 6 cases had intracranial hypotension.Catheter blockage occurred 15 cases, 6 cases made bold to draw the tube by themselves, 5 cases had seepage, 6 cases had inadequate drainage, subdural effusion occurred in 1 case, radiculalgia occurred in 3 cases.Conclusions lumbar cistern set tube drainage can rapidly drain bloody cerebrospinal fluid, shorten the duration of treatment for patients with subarachnoid hemorrhage and accelerate patient recovery.The causes of complications include improper operation and catheterization, excessive drainage, and patients with low compliance.According to the different causes of the complications, corresponding measures should be taken in clinic to decrease the incidences of the complications, which include improvement of operation skills, paying attention to control drainage rate and drainage time, and improvement of the patients' compliance.Reported events: three patients experienced failed catheter intubation.Six patients experienced intracranial hypotension.Fifteen patients experienced catheter blockage.Six patients experienced disconnection (catheter pulled out by patient).It was stated this was due to the patients being confused, restless, or having dementia.Five patients experienced seepage (csf leak from puncture site after removal of drainage catheter).Six patients experienced inadequate drainage.Three patients experienced radiculalgia.It was stated to be caused by contact between drainage catheter and nerve root, due to malposition of catheter.

Manufacturer Narrative

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

• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7258515
• MDR Text Key: 100041898
• Report Number: 2021898-2018-00073
• Device Sequence Number: 1
• Product Code: GWM
• 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,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 04/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR