MAUDE Adverse Event Report: UNK MEDSTREAM; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 09/17/2015

Event Type  Injury  

Manufacturer Narrative

Udi: unknown part number, udi unavailable.In the first case (the pump catheter damaged as the result of intense physical activity twice), a catheter disconnection (if any) could be explained by a patient intense physical activity.To avoid this type of issue, a ¿loop¿ can be made with the catheter to give more flexibility to the it system and allow patient movements.Also different types of anchors are provided with the catheter to secure it.We can¿t status on a pump defect for the second case with such a vague description (one patient had problems with incorrect functioning of the pump which was solved by replacing the pump.) without the pump(s) and pump information such as serial number it is not possible to perform an evaluation and determine the root cause of the reported incidents or review the device history records.We will continue to monitor for this or similar complaint for the medstream pump.At the present time this complaint is closed.Device not available.

Event Description

In the conference abstract found in a literature search ¿optimization of the treatment of spasticity in patients after severe spine trauma¿ published stereotactic and functional neurosurgery.2014 sep; conference: 21st congress of the european society for stereotactic and functional neurosurgery: implementing research in clinical applications maastricht netherlands.Conference start: 20140917 conference end: 20140920.Conference publication: (var.Pagings).92 :s227., it was reported that two patients with unknown medstream pumps implanted had product malfunctions.One patient had the pump catheter damaged as the result of intense physical activity twice, there was no report of the treatment for this issue.One patient had problems with incorrect functioning of the pump which was solved by replacing the pump.Per the abstract: ¿treatment of the consequences of traumatic damage of the spine and spinal cord is one of the most acute issues in the modern world.Development of heavy spasticity syndrome after spinal cord injury is widely spread and comprises up to 60% of all cases according to different sources of literature.The aim of the research is to optimize medical assistance to the spinal cord injury patients with spasticity syndrome.Methods: our research is based on the analysis of 23 cases.All patients suffered from heavy spasticity syndrome after spinal cord injury which made impossible the process of rehabilitation and lowered the quality of life¿.Despite the fact that baclofen pump is the mostly used around the world, the results of our research has shown that the method of spinal cord stimulation is not less effective in the treatment of heavy spasticity syndrome after spinal cord injury and might be applied in the world practice along with baclofen therapy.¿ at the time of complaint entry no device specific information, i.E.Catalogue/lot number, is available.

• Brand Name: UNK MEDSTREAM
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5836478
• MDR Text Key: 50838289
• Report Number: 1226348-2016-10534
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention