San Diego, CA (PRWEB) January 28, 2014
Resource4thePeople announced today that its national network of attorneys will resume offering free consultations in 2014 to consumers inquiring about legal options to seek compensation in connection with the recall of Medtronic SynchroMed Infusion Pumps.
The Food and Drug Administration recall* 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.
“We are proud to announce that our policy of providing these consultations to consumers inquiring about the possibility of having suffered health problems identified by the FDA in connection with these medical devices will resume in 2014,” said Resource4thePeople.
The announcement of the continuation of complimentary consultations is being made in response to numerous inquiries from consumers about whether Resource4thePeople's national network of attorneys would, after 2013, continue to offer this service, said Resource4thePeople.
“The continued increase in the number of consumers inquiring about allegations of dangerous side effects from Medtronic Infusion Pumps identified by the FDA demonstrates that there are a great number of affected consumers seeking experienced, aggressive legal help,” said Resource4thePeople.
Resource4thePeople also is announcing that it will continue to provide consumers with updates about the latest developments involving these serious health concerns, including any additional information released by the FDA.
What were described as life-threatening health concerns by the FDA involving Medtronic SynchroMed Infusion Pumps were contained in a Class 1 Recall Notice issued by agency officials June 13, 2013.
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).
Resource4thePeople also has established an information bank that includes details of the recall and a link to the FDA web site. Also included on the site are details of products affected by the recall and the toll-free telephone number to seek a free consultation.
Among the most recent developments involving the pumps is an acknowledgment by a Medtronic official in interviews with 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."
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."