MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; LUMBAR DRAIN

Model Number 27200329

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/21/2016

Event Type  malfunction  

Event Description

A lumbar drain was being inserted in the operation room by a surgeon and the drain could not be advanced.It was removed and another attempt to place it was made.Again, it could not be advanced and upon attempting to remove it, the drain broke off in the patient.Mri and ct scans showed a 4-5 cm portion of the drain to be in the spinal canal extending from t12-l2.Physicians decided to leave the piece in place and follow the patient with serial x-rays.

• Brand Name: MEDTRONIC
• Type of Device: LUMBAR DRAIN
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 5543848
• MDR Text Key: 41826208
• Report Number: MW5061436
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/30/2016

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: Health Professional
• Device Model Number: 27200329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR