Medtronic Bone Graft Death Lawsuit
The Plaintiff Shirley Nisbet underwent neck surgery on August 21, 2008, during which a Medtronic Infuse Bone Graft was implanted in the cervical area of her spine.
It is important to note that the Medtronic Infuse Bone Graft was only approved by the FDA for use in the lumbar spine and for certain dental procedures. However it has been used on thousands of occasions where it is installed in the neck during surgery of the cervical spine and unfortunately the implanting of the Infuse Bone Graft in the neck has been associated with a number of life-threatening complications.
Following the Plaintiff’s surgery, she suffered respiratory arrest on August 23, 2008 and went into a coma. She was kept alive by artificial life support until her death on August 30, 2008.
Her family filed a Medtronic Infuse wrongful death lawsuit on December 2, 2008 in Los Angeles, alleging that Medtronic failed to warn about the risks associated with use of the bone stimulator in the neck and claims that the device maker actively encouraged the off-label use. The lawsuit indicates that a Medtronic representative was in the operating room before and during Nisbet’s surgery.
Medtronic notified the FDA in August 2008 that Shirley Nisbet had trouble breathing after the spinal-fusion surgery and had fallen into a come four days after she received the Medtronic bone stimulator implant. However, the company never reported that she later died.
According to the Wall Street Journal, Medtronic, Inc. has indicated or contends that they were unaware that Nisbet passed away less than 10 days after her surgery. However, Medtronic has not indicated what, if any, follow up requests were made about Nisbet’s status after they were notified she went into respiratory arrest and a coma.
The Medtronic Infuse Bone Graft contains a synthetic material that is implanted to encourage bone growth. Given the close proximity of the cervical spine to the airway, use of the bone stimulator in the neck has been associated with reports of swelling that may compress the airway and nerves, potentially leading to difficulty breathing, inability to speak, trouble swallowing, respiratory arrest or death.
In July 2008, the month before Nisbet’s surgery, the FDA warned that such off-label use in the cervical spine or neck, has been associated with a number of adverse event reports.
In November 2008, Medtronic disclosed that they are facing an investigation by the U.S. Justice Department into their alleged off-label marketing and promotion of the Infuse Bone Graft, which would violate federal law.
The Nisbet case is believed to be the first lawsuit filed by a patient who was injured by the bone stimulator. However, investors have filed a Medtronic Infuse class action suit alleging that the company made false and misleading statements about the bone stimulator and injury lawyers, including lawyers with our Law Firm are reviewing potential Medtronic Infuse Bone Graft claims on behalf of individuals who have experienced complications with use of the device in the cervical spine.
If you or a family member need more information on this mater – call our Offices at 1-800-862-1260.
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Other Medtronic recall information:
Currently our Law Firm is providing patients who have been injured by the Medtronic Sprint Fidelis Cardiac Lead or those that may need a Lead Replacement with information. Please call us for more information. Our Law Firm is also evaluating if those affected by this recall may be entitled to financial compensation. Please complete the form to the left or call 1-800-862-1260.
Urgent Class I Recall Notice for the Medtronic Sprint Fidelis
The FDA has annouced that any patients who received a Medtronic Lead in the last three years to seek immediate medical attention for the Medtronic Sprint Fidelis Lead can cause:
- Fainting;
- Palpitations;
- Inappropriate Shocks resulting in Death;
- Lightheadedness;
- Other Unusual Symptoms
What is a Medtronic Sprint Fidelis Lead?
Manufactured by Medtronic, Inc., Sprint Fidelis Leads are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that protect patients when life-threatening heart rhythms occur. Our Law Firm is providing patients who have been injured by the Medtronic Sprint Fidelis Cardiac Lead or those that may need a Lead Replacement with information. Please call us for more information. Our Law Firm is also evaluating if those affected by this recall may be entitled to financial compensation. Please complete the form to the left or call 1-800-862-1260.
How do defibrillators work?
Defibrillators monitor heart rhythms. They deliver an electrical shock or rapid pacing to restore normal rhythm when life-threatening, irregular heartbeats are detected. These devices keep the heart from going too fast. They are surgically implanted for patients who are at risk of sudden cardiac arrest. Our Law Firm is providing patients who have been injured by the Medtronic Sprint Fidelis Cardiac Lead or those that may need a Lead Replacement with information. Please call us for more information. Our Law Firm is also evaluating if those affected by this recall may be entitled to financial compensation. Please complete the form to the left or call 1-800-862-1260.
What Doctors Can Do If You Have a Medtronic Sprint Fidelis Lead.
Patients should consider and discuss with their doctors alternative available which include;
- Removing the Medtronic Sprint Fidelis Lead through surgery;
- Continue to use the Medtronic Lead while monitoring closely for signs of fracture;
- Add a replacement lead. This does not require removing the Medtronic Sprint Fidelis lead. If the Spring Fidelis lead is left in the patient without being used, it must be “capped”, which means covering the tip with a small plastic insulation.
