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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC LP SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC MEDTRONIC LP SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 44430
Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)
Patient Problems Bacterial Infection (1735); Cerebrospinal Fluid Leakage (1772); Dyspnea (1816); Swelling (2091); Ambulation Difficulties (2544); Foreign Body In Patient (2687)
Event Date 07/07/2011
Event Type  Injury  
Event Description
On (b)(6) 2011 i had a medtronic lp strata ii shunt installed (44430/lot# c78605). After 27 revisions (due to shunt malfunction varying from tubing coming loose, to tubing tangled in abdominal cavity, to magnetic field setting not "setting" properly) i eventually had the shunt removed in 2011. However, my problems did not cease to exist. I developed a spinal fluid leak at abdominal and back incision site. I was admitted into hospital for almost 6 months, had nurses/doctors and interns come in every 30 mins to "push" fluid out, sheets changed 20-30 times daily, several "gauze packing attempts" only to be left sent home with a home health nurse and iv rocephin, administered daily, due to (b)(6) in my spinal cord caused by the continual gushing of spinal fluid out of my spine and abdomen, due to lack of competency by nurses. I was so drugged up that i did not realize what was happening and one day finally asked them to please use gloves when trying to "extract" spinal fluid. At one point i had a softball size knot appear on my spine, at valve site, and eventually rupture gushing spinal fluid everywhere! since removal i have had continual non stop problems and even developed an additional spinal fluid leak that had to be repaired by dr (b)(6) at (b)(6) university in 2015. Prior to the repairing leak, i was unable to stand for longer than 2-3 min at a time and was leaking spinal fluid in back and backing up, dripping out of my nose. It was by accidental finding (went to emergency room complaining of right abdominal swelling, shortness of breath, headache and extreme altered vision) that they did a ct of abdomen and it revealed a 18" section of tubing for medtronic lp shunt was still left inside me and was now located between l-1 and s-2 and was pressing on a nerve to my left leg, causing a constant feeling of leg being on fire. I went back to the neurosurgeon who initially installed and then "removed" the lp shunt and was informed a portion of the tubing had broken off during removal and there was nothing he could do about it. "these things happen". While i continue to have debilitating daily symptoms, i fail to accept that these things happen! my medtronic shunt failed from day one and now i am stuck with a portion of it, irremovable, in my spine. Along with (b)(6) plus in medical bills only to find out that the product they installed in my body has since been recalled and yet i still have no answers on how to proceed forward.
 
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Brand NameMEDTRONIC LP SHUNT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6521839
MDR Text Key73860358
Report NumberMW5069318
Device Sequence Number1
Product Code JXG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number44430
Device Lot NumberC78605
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/24/2017 Patient Sequence Number: 1
Treatment
OTC MEDS: BIOTIN B-12. ; POTASSIUM 99MG DAILY; RX MEDS: DIAMOX 100MG DAILY; TOPERAL OTC ; VITAMINS.
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