San Diego, CA (PRWEB) October 21, 2013
Resource4thePeople announced today that its national network of lawyers are now reviewing allegations from consumers who may have suffered health problems as a result of Medtronic Infusion Pumps that were the subject of a recall by the Food and Drug Administration.
The FDA in a June 3, 2013 Class 1 Recall Notice* alerted health care professionals and consumers that electric shorting problems had been identified in the Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps.
In its notice, The FDA said the pumps contain and administer prescribed drugs to a specific site inside the patient’s body. Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorph, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen. The SynchroMed pumps are used to treat primary or metastatic cancer, chronic pain, and severe spasticity.
"The FDA said that in instances in which the problems that generated the recall occurred patients may have been placed in life-threatening situations," said Resource4thePeople.
"In response to the numerous inquiries we have been receiving from consumers over these recalls were are now reviewing allegations of health problems and offering free consultations about legal options that may be available to seek compensation for those who may have been injured."
The FDA describes Class 1 recalls as the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The FDA listed this Reason for Recall:
"There is a potential for electrical shorting, internal to the SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and may lead to a loss of or reduction in therapy. This may result in the return of underlying symptoms and/or withdrawal symptoms. Use of this recalled product may result in serious adverse health consequences, including death."
The models identified by the FDA are the SynchroMed II, Model 8637 (20 ml or 40 ml reservoir size) and SynchroMed EL Programmable Pumps, Models 8626, 8626L, 8627, 8627L (10 ml or 18 ml reservoir size).
"If you have been injured because of factors described by the FDA recall involving malfunctioning Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump, you may have a right to seek compensation for your injuries," said Resource4thePeople.
"Our experienced, aggressive national network of attorneys is now available to review the facts of your case and advise you of the legal options that may be available to you to seek compensation for medical costs, treatment, pain and suffering and other expenses."
Consumers should not confuse these products 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.
"However, Medtronic's marketing practices were the subject of a scathing review by U.S. Senate investigators in a report that was issued last year and raised serious questions involving the marketing of the Infuse," said Resource4thePeople.
Here is a part of the report** which was released by the U.S. Senate Finance Committee on October 25, 2012:
"Without public disclosure of their roles, Medtronic employees collaborated with physician authors to edit – and in some cases, write – segments of published studies on its bone-growth product InFuse. The studies as published may have inaccurately represented InFuse’s risks and may have placed added weight on side effects of alternative treatments. Medtronic, which describes itself as 'the world's largest independent medical technology company,' also maintained significant, previously-undisclosed financial ties with physicians who authored studies about InFuse, making $210 million in payments to physicians over a 15-year period."
In a press release*** issued as part of the FDA Class 1 Recall Notice involving the SynchroMed Pumps, Medtronic officials provided additional details about the shorting problem:
"Medtronic has issued an Urgent Medical Device Correction notification to inform physicians about the potential for an electrical short within the SynchroMed pump. The FDA has classified this notification as a Class I recall.
"An electrical short could lead to pump motor stall and a subsequent loss of or reduction in therapy, which can result in the return of underlying symptoms and/or withdrawal symptoms. The SynchroMed II pump is equipped with alarms designed to alert the patient in the event of a motor stall.
"Medtronic encourages patients to contact their physicians immediately if they experience a return of symptoms or hear a device alarm. The cumulative failure rate due to this issue is less than one percent at seven years post implant. Because of the estimated low occurrence rate, the alarm safety feature and the risks associated with replacement surgery, Medtronic is not recommending removal of the devices unless a patient's pump shows signs of a malfunction. Medtronic is in the process of developing design updates to mitigate this issue."
Medtronic also provided the following details of how the devices are used:
"Physicians implant the devices in recipients’ lower abdomens underneath the skin, with one end of a catheter inserted into the intrathecal space in the spine and the other end connected to the device. Their purpose is to inject a predetermined amount of prescription painkillers into recipients’ spines at a preprogrammed rate or time. Both devices received FDA approval for injecting morphine, ziconotide, Lioresal (baclofen), floxuridine, and methotrexate. Medtronic has sold about 140,000 SynchroMed Implantable Infusion pumps"
The FDA also said that health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch, the FDA's Safety Information and Adverse Event Reporting Program.