MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC LP SHUNT KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 44430

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Device Embedded In Tissue or Plaque (3165)

Event Date 07/07/2011

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to medtronic neurosurgery that the patient had the device installed on (b)(6) 2011.According to the report, after 27 revisions due to shunt malfunction varying from tubing coming loose, to tubing tangled in the abdominal cavity, and to magnetic field setting not setting properly, they had the shunt removed on (b)(6) 2011.However, it was stated that the patient's problems didn't cease to exist, and they developed a spinal fluid leak at the abdominal and back incision site.They were admitted into the hospital for almost 6 months and had nurses, doctors, and interns come in every 30 minutes to push fluid out, change sheets 20-30 times a day, and have several "gauze packing attempts" only to be sent home with a home health nurse and iv rocephin administered daily due to the continual gushing of the spinal fluid out of their spine and abdomen.It was stated they were so drugged up that they did not realize what was happening, and one day finally asked them to the nurses to please use gloves when trying to extract spinal fluid.Reportedly, at one point, the patient had a softball size knot appear on their spine and at the valve site that eventually ruptured and gushed spinal fluid everywhere.It was stated since removal, they have had non stop problems, and even developed an additional spinal leak that had to be repaired by the doctor in 2015.Prior to repairing the leak the patient was unable to stand for longer than 2-3 minutes at a time and was leaking spinal fluid in the back and backing up, dripping out of their nose.It was noted that by accident when they went to the emergency room complaining of right abdominal swelling, shortness of breath, headache, and extreme altered vision that they did a ct of the abdomen.It revealed a 18 inch section of tubing from the device was still left inside the patient and was located between l1 and s2 and was pressing on a nerve to their left leg causing a constant feeling of the leg being on fire.The patient went back to the neurosurgeon who initially installed and removed the device, and they were informed portion of the tubing had broken off during removal.It was stated there was nothing the neurosurgeon could to about it and it was irremovable from the spine.

Manufacturer Narrative

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

• Brand Name: STRATA NSC LP SHUNT KIT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• 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: 6620752
• MDR Text Key: 76946060
• Report Number: 2021898-2017-00313
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K033850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: 44430
• Device Lot Number: C78605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2010
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention