Medtronic Infusion Pump Lawsuits
If you have been injured because of a malfunctioning Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pumps, you may have a right to join a class action lawsuit. If you used these infusion pumps and think you may have been hurt because of it, calling a personal injury or medical malpractice lawyer could be your next step.
Do not confuse this with the Medtronic INFUSE Bone Graft product, as no current FDA recalls have taken place on the INFUSE Bone Graft product, INFUSE has been continuously approved by the FDA since 2002.
The Food and Drug Administration has announced a Class 1 Recall of the Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits. SOURCE: http://www.fda.gov/medicaldevices/safety/listofrecalls/ucm359111.htm
The pump and infusion system are used in patients undergoing therapy that requires the constant delivery of drugs or fluids into a patient’s body. The refill kit is used in refilling most Medtronic implantable infusion pumps.
The federal agency warned that pocket fills, or the unintended injection of drugs or fluids into the patient’s subcutaneous tissue at the pump pocket site instead of the pump, may result in patient harm, serious injury and/or death due to drug overdose or underdose.
The affected products are:
- SynchroMed II (Model No. 8637)
- SynchroMed EL (Model Nos. 8626 and 8627)
- Refill Kits (Model Nos. 8551, 8555, 8561, 8562, 8564, 8565 and 8566.
The federal agency is recommending that health care professionals check needle placement within the pump septum during the drug refill procedure. Medtronic is warning that it is essential that the needle be inserted through the refill septum until it has reached the needle stop in the pump reservoir. At every refill, patients and caregivers should be reminded about the signs and symptoms of drug overdose, underdose and withdrawal, the FDA said.
The agency encouraged health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA’S MedWatch Safety Information and Adverse Event Reporting Program. Forms are available on the agency’s Web site at www.fda.gov/MedWatch/report.htm. The recall was announced Feb. 16 at the FDA headquarters in Silver Springs, Md.
Other Recalled Defibrillators and Pacemakers
Recalled Pacemaker Models:
- Sigma 100S (Models SS103, SS106)
- Sigma 200D (Model SD203)
- Sigma 200DR (Model SDR203)
- Sigma 200S (Model SS203)
- Sigma 200SR (Model SSR203)
- Sigma 300D (Model SD303)
- Sigma 300DR (Models SDR303, SDR 306)
- Sigma 300S (Model SS303)
- Sigma 300SR (Models SSR303, SSR306)
Recalled Defibrillators or Combination Devices:
- 7230 Marquis VR
- 7274 Marquis DR
- 7232 Maximo VR
- 7278 Maximo DR
- 7277 InSync Marquis
- 7289 InSync II Marquis
- 7279 InSync III Marquis
- MicroJewell II Model 7223Cx
- Gem DR Model 7271
The Problem with Medtronic Defibrillators and Pacemakers
Medtronic recalled about 28,000 pacemakers worldwide because the wire could separate from the battery. Most of the pacemakers prone to this problem had already been replaced because of normal battery depletion. About 6,650 people in the US still had these pacemakers in, and most were due to be replaced soon. No serious medical problems were reported due to this defect.
Medtronic also recalled about 87,000 defibrillators because of a problem with the battery. The battery would short out, and would run down very quickly and suddenly, causing the defibrillator to fail. At least one serious injury and four deaths happened because of this defect.
Nearly all the Medtronic defibrillators and pacemakers recalled were manufactured before 2003.
Signs and Symptoms
If your pacemaker or defibrillator fails, you could experience shortness of breath, dizziness, confusion, a very slow or very fast pulse, heart flutters, loss of consciousness or death.
Several people with Medtronic defibrillators and pacemakers that were defective noticed that their "pocket," where the device was implanted under the skin, was warm.
Some Medtronic defibrillators and pacemakers have a sort of "low battery alarm," which beeps if the battery gets too low. However, most of the defective batteries lost their charge so quickly that the alarm didn't go off.
If you experience symptoms or if you notice unusual warmth around your pacemaker, or if you hear beeping from your pacemaker, seek medical attention immediately.
If you have been injured because of defects in Medtronic defibrillators and pacemakers, you may be entitled to compensation for injury-related expenses and other costs.
Recalled Infusion Set Model Numbers:
- MMT 359S6
- MMT 359S9
- MMT 359L6
- MMT 359L9
The Problem with Medtronic Minimed Diabetic Infusion Sets
Medtronic released an updated version of their diabetic infusion sets, the Medtronic Minimed Diabetic Infusion Set. People who used the new set complained that it didn't work as well as the old one, and that they preferred the old set over the new one. Medtronic offered to replace any defective infusion sets, and gave them information to help them use the sets better.
Despite customer complaints, Medtronic discontinued the old infusion sets, forcing everyone to convert to the Medtronic Minimed Diabetic Infusion Sets listed above in the recall list. People continued to complain about the new infusion sets, and many felt that Medtronic was unresponsive to their complaints.
Finally, in May 2004, after several serious injuries and hospitalizations, Medtronic and the FDA issued a recall of the Medtronic Minimed Diabetic Infusion Sets. Medtronic asked its customers to stop using the sets immediately, and replaced them for free. They issued guidelines for how to manage their insulin if the patient had to wait for a new set to arrive.
There were several problems with the Medtronic Minimed Diabetic Infusion Sets that caused the flow of insulin to be interrupted. These included bent cannulas, tubing that got kinked and occluded, leaking around the insertion site and adhesive failure that allowed the tubing to get dislodged.