Medtronic Device Recalls

Medtronic Suspends Distribution of Sprint Fidelis Defibrillator Leads

FDA ALERT ISSUED: October 17, 2007 - 10-17-2007: FDA ISSUES MEDTRONIC RECALL:

Audience: Cardiologists, emergency services personnel, risk managers, consumers
[UPDATED 10/17/2007] FDA issued a Class I Recall of Medtronic Inc. Sprint Fidelis Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007. Patients who are implanted with this lead, or do not know the model of their lead, should contact their physicians for further information.

10/16/2007 - FDA issued a statement announcing Medtronic's decision to voluntarily suspend distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company.

This includes four Sprint Fidelis Models: 6930, 6931, 6948, and 6949.

When a defibrillator lead is slightly more prone to fracture, most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures,"
the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.

Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. Patients who are implanted with this lead are encouraged to contact their physicians for further information. (read FDA MedWatch alert)

Medtronic Device Recalls

Medtronic ICD

Medtronic is one of the world’s largest manufacturers of medical devices. One of its biggest sellers was their implantable cardioverter defibrillators, or ICDs. These are sophisticated heart rhythm devices that help monitor and detect irregular heartbeats and provide electrical stimulation to induce proper rhythm.

Unfortunately, these devices require precision manufacturing to function properly, and if one aspect of it fails it jeopardizes not only the machine, but the person who depends on it. Medtronic stated that there were potentially 87,000 ICDs that could fail under certain circumstances, and over 200 of the devices failed before February 2006. 19,000 people required surgery to remove and replace the failed devices, and one man died from post surgical complications.

Furthermore, Medtronic does not always offer enough compensation for their mistakes. There have been many reports of post-operative complications far outmatching the amount Medtronic is willing to pay, and many people who have needlessly suffered because of Medtronic’s mistake now have to finance their expenses out of their own pocket. There are about 2,000 lawsuits pending against Medtronic right now, and more will likely continue to pour in as people are now discovering Medtronic continued to sell ICDs they knew to be defective.

Make sure that if you or someone you love was injured due to the negligence of Medtronic that you consult a dedicated and experienced defective medical device attorney right away. Statutes of limitation laws restrict the amount of time you have to take legal action, and if you wait too long you could miss out on the financial restitution you deserve. Contact a lawyer today.

Medtronic Pacemaker

Medtronic Inc. is one of the world’s largest manufacturers of cardiac devices such as pacemakers. Pacemakers are small machines that provide electrical stimulation to injured or damaged hearts in order to ensure proper heart rhythm and steady beat. Unfortunately, in November of 2005, Medtronic recalled almost 40,000 Sigma pacemakers due to a potentially life-threatening defect, and 28,000 of these devices are still in patients around the world.

The company said that a solvent used to clean the pacemaker wires could cause them to degrade prematurely, preventing proper function and significantly shortening the lifespan of the device. According to records provided by Medtronic, there are between 47 and 84 units manufactured between November 2001 and August 2004 that could potentially suffer from this defect during the 10-year lifespan of the devices.

Unfortunately, there have been 19 failures of these devices. There have been no reports of fatalities due to this malfunction, but any failure of a pacemaker can be serious because there are generally few easily recognizable symptoms of loss of output. Also, Medtronic has advised anyone with a Sigma series pacemaker to contact their doctor for the appropriate course of action.

If you or someone you love depends on a Medtronic Sigma pacemaker, you need to consult an experienced and knowledgeable defective medical device attorney immediately. You could be eligible to recover financial restitution for your expenses, pain, and suffering, but if you wait too long you risk running out of time under the statute of limitations. You deserve justice. Contact a defective medical device attorney today.

Advisories or recalls have been annouced for the following Medtronic devices:

Sigma Implantable Pulse Generators
Original Date of Advisory: November 2005
Potential Separation of Interconnect Wires

Marquis Family of ICDs and CRT-Ds
7274 Marquis DR 7277 InSync Marquis
7230 Marquis VR 7289 InSync II Marquis
7278 Maximo DR 7279 InSync III Marquis
7232 Maximo VR 7285 InSync III Protect
Recalled:February 2005
Potential Premature Battery Depletion Due to Battery Short

7223 Micro Jewel II
7271 GEM DR
Original Date of Advisory: April 5, 2004
Potential Long Charge Times Due to Capacitor – Supplement

AT500 Pacing System
Original Date of Advisory: September 15, 2003
Potential Incorrect Memory Circuit Setting

7271 GEM DR ICDs
Original Date of Advisory: November 14, 2002
Potential Sudden Increase in Charge Times

Kappa 600, 700 Dual Chamber (D, DR, and VDD) IPGs
Original Date of Advisory: March 15, 2002
Potential Fractured Power Supply Wires

7227 with Interchangeable Connector System
Original Date of Advisory: December 20, 2000
Potential High Impedance Due to Removable Connector Header

7223Cx Micro Jewel II ICDs
Original Date of Advisory: November 20, 2000
Potential Long Charge Times Due to Capacitor

7273 GEM II DR
7229Cx GEM II VR
Original Date of Advisory: February 11, 2000
Potential Weak Solder Connection

7271 GEM DR ICDs
Original Date of Advisory: December 16, 1999
Potential Long Charge Times Due to Capacitor

7227Cx GEM
7229Cx GEM II VR
Original Date of Advisory: October 15, 1999
Potential Circuit Overload

Sigma Implantable Pulse Generators
Original Date of Advisory: September 27, 1999
Manufacturing Issue

7227Cx GEM ICDs
Original Date of Advisory: April 2, 1999
Potential High Current Drain

Thera Implantable Pulse Generators
Original Date of Advisory: February 18, 1997
Potential Integrated Circuit Failure

4504, 4504M CapSure Atrial Lead
4582 Target Tip Atrial Lead
Original Date of Advisory: October 4, 1996
Lead Survival Below Expectations

8446, 8448 Legend Plus IPGs
Original Date of Advisory: June 14, 1996
Potential for Improper Programming

4004, 4004M CapSure Ventricular Lead
4082 Target Tip Ventricular Lead
Original Date of Advisory: October 8, 1993
Lead Survival Below Expectations

4012 Target Tip Ventricular Lead
Original Date of Advisory: September 26, 1991
Lead Survival Below Expectations

Minix, Minix ST, Micro Minix IPGs
Original Date of Advisory: May 6, 1991
Potential Delayed Restoration of Permanent Settings

Other Defective Medical Device Topics

• Bard Composix Kugel Mesh Patch
• Baxter Hemodialysis Machine
• Baxter Dialysis Filter
• Blackstone Medical ICON Modular Fixation System
• Boston Scientific Express Stent & Taxus Stent
• Boston Scientific Flextome Cutting Balloon Device
• Cardinal Health Alaris Pump
• Cochlear Implants
• Colleague Volumetric Infusion Pumps
• Cordis Corporation Balloon Catheters
• Guidant Device Recalls

• Johnson & Johnson Cypher Stent
• Medtronic Device Recalls
• Medtronic ICD
• Medtronic Pacemaker
• Minimed Diabetic Infusion Set
• Olympus Bronchoscope
• Oxygen Regulator Fires
• Shoulder Pain Pumps
• St Jude Device Recalls
• Shelhigh Medical Devices
• Stryker Hip Replacement
• Tainted Tissue
• Thermage Defective Device