MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY LUMBAR DRAINAGE KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Device Problems Material Separation (1562); Torn Material (3024)

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

Event Date 09/09/2016

Event Type  malfunction  

Event Description

Lumbar drain came apart at flexible catheter point and actually drain point.Patient stated that when he was in bed, and moved he felt a "tear or pulling of tape" and called nursing immediately.Nursing inspected site and found flexible catheter still inserted in lower back, and sutured in place.Doctor notified.

• Brand Name: LUMBAR DRAINAGE KIT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona dr.; goleta CA 93117
• MDR Report Key: 5993275
• MDR Text Key: 56186283
• Report Number: 5993275
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2016,09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2016
• Device Age: 4 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NONE IDENTIFIED PATIENT RT MONITORING, CONTINUOUS
• Patient Age: 61 YR
• Patient Weight: 103