San Diego, CA (PRWEB) November 12, 2013
Resource4thePeople announced today its latest update for consumers who may have been affected by life-threatening health problems from Medtronic SynchroMed Infusion Pumps that were the subject of a Class 1 Recall Notice* by the Food and Drug Administration.
Among the most recent developments involving the pumps is an acknowledgment by a Medtronic company official that 14 patients using the pumps have died in the last 17 years, according to a June, 27, 2013 Bloomberg News article.**
"Fourteen patients have died since 1996 while using the SynchroMed System, Donna Marquard, a Medtronic spokeswoman, said yesterday," according to Bloomberg. "The most common complication was the inadvertent injection of a drug into the patient's subcutaneous tissue, rather than into the pump, which led to 11 deaths. Two patients died from a blockage and another from an electrical short."
"Millions of people put their trust in medications and medical devices to safely treat their conditions but sometimes such products are the subjects of recalls because they threaten the health and lives of patients," said Resource4thePeople.
"The devastating consequences of some of these products provide some consumers the right to seek compensation for the injuries they or loved ones have suffered and our national network of attorneys is maintaining its policy of offering free consultations in such cases."
In its posting, Bloomberg News reported that the "SynchroMed Infusion pumps were found to have four flaws that have led to 14 patient deaths, spurring U.S. regulators to issue their most serious recall on the implantable device used to deliver pain and other medications."
The FDA recall notice was issued June 3, 2013 and warned health care professionals and consumers that electric shorting problems had been identified in the Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps.
FDA officials 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 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:
"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."