San Diego, Ca (PRWEB) December 02, 2013
Resource4thePeople announced today that it has opened a new information bank 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.
"This information is being provided as a result of the increasing number of inquiries we have been receiving from consumers about what legal options they may have to seek compensation about health problems cited by the FDA," said Resource4thePeople.
"In addition to the new information bank we are also announcing that our national network of attorneys will continue to offer free consultations about the legal options that may be available to families affected by the details of this recall."
The information bank includes details of the June 3, 2013 recall and a link to the FDA web site. Also included on the site are details of which products were affected by the recall and the toll-free telephone number to seek a free consultation.
"It has become apparent from the consumer inquiries we have been receiving that many of them were not aware of the FDA recall," said Resource4thePeople.
"Given that this was a Class 1 recall -- which is issued only in the most serious recalls -- we are urging all consumers who may have been affected by this recall to review this information and contact us as soon as possible to preserve their legal options."
The FDA recall notice 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 recalls that 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).
Among the most recent developments involving the pumps is an acknowledgment by a Medtronic company official in interviews with several major media outlets that 14 patients using the pumps have died in the last 17 years. Among those interviews was one reported in 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 but sometimes such products are the subject of recalls because they threaten the lives of patients," said Resource4thePeople.
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."
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 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."