Baclofen pump ordered withdrawn – UPDATED!

Medtronic ordered to stop selling it

 

The US Food & Drug Administration (FDA) have catalogued problems with Medtronic’s SynchroMed pumps since 2006, but have now taken the drastic step to order the company to stop selling the pumps because of a failure to effectively address serious malfunctions that have been associated with death in some 14 cases.

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These pumps can be used for the administration of intrathecal baclofen and some HSPers may be fitted with them.

 

UPDATE!  The Therapeutic Goods Administration (TGA), Australia’s regulatory body for medicinal drugs and medical devices issued a press release in late May concerning the FDA’s banning of the Medtronic pump.

 

Here is an extract from the TGA’s press release:

The TGA is aware of regulatory action undertaken by the US Food and Drug Administration (FDA) in relation to the SynchroMed drug infusion system. The consent decree requires Medtronic to undertake the required actions globally and Medtronic Australasia will be implementing them in Australia from 15 June.The TGA is reviewing information supplied by Medtronic Australasia regarding this issue. The TGA will continue to monitor the safety and performance of SynchroMed drug infusion systems and will take appropriate regulatory action if a safety concern becomes apparent. In accordance with its usual procedures, the TGA will also continue to liaise closely with the FDA and other international regulators on this and similar issues.

The press release goes on to provide information for consumers and health professionals. Read the full press release from the TGA.

 

Below is extracted from 2 press releases in April in the USA:

MINNEAPOLIS _ Medtronic has entered an agreement with the Food and Drug Administration to stop selling an infusion pump except in rare cases because the company failed to fix manufacturing problems that may cause the implantable devices to deliver too much or too little medication.

 

The FDA on Monday announced the filing of a consent decree with the Ireland-based maker of medical devices, along with its chief executive Omar Ishrak and Thomas Tefft, president of the division that makes the Synchromed II implantable drug pump. The devices are made at a Minneapolis-area Medtronic’s plant.

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The consent decree doesn’t say Medtronic is admitting liability, but it does halt most sales and manufacturing of the device until the FDA decides that the company has addressed the problems, first documented in 2006.

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The agreement, which still requires court approval, allows the company to sell a device “in very limited cases,” including situations where a doctor determines the device is medically necessary for a patient’s treatment.

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Medtronic spokeswoman Cindy Resman said that for patients who need a replacement pump, the company will have to get physician certification showing the patient has been informed about the FDA consent decree. For new patients, the certification must show that the patient knows of the agreement and the doctor still believes the benefits of the therapy outweigh the risks.

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An announcement from the FDA said between 2006 and 2013, five inspections at the company’s neuromodulation plant resulted in three warning letters disclosing major violations involving the Synchromed II pumps, which were first approved for sale in 2004.

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The violations included problems with how the company identified, investigated and corrected quality problems with the device, and its failure to document design changes. The company also failed to ensure the finished products met design specifications, the FDA said.

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The failure to implement more rigorous manufacturing controls violated the rules in the federal Food, Drug and Cosmetic Act, turning the pumps into adulterated medical devices, the complaint for permanent injunction accompanying the consent decree says.

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“Defendants are well aware that their practices violate the Act,” the complaint says. “FDA has repeatedly warned defendants, both orally and in writing, about their violative conduct, and has emphasized the importance the defendants’ compliance with the act.”

 

In June 2013, Medtronic acknowledged that 14 deaths had been associated with SynchroMed pumps since 1996. They included two people whose devices had blocks in the tube that delivers pain medication, and 11 cases in which the drugs were inadvertently injected into tissue around the pump rather than into its reservoir. One death was connected to a short-circuit in the device.

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Word of the deaths came after the company told doctors about potential problems with the pump and issued special instructions for its use. The FDA later classified that communication as a Class I recall, which is the most critical type.

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A Medtronic statement said the agreement, which is still subject to court approval, does not require the retrieval of any device, and patients with the pumps do not need to change their course of therapy. “We are committed to the highest level of quality, and have pursued significant efforts in recent years to enhance the performance of the pump and to address the FDA’s expectations,” Tefft said in a statement. “We are confident that our efforts to date will contribute to the timely and thorough completion of these activities.”

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Physicians have long known about issues with the device, but they say there are few alternatives on the market. The FDA said Monday that problems with how the device is made can cause it to deliver too much or too little medication, or to delay therapy.

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Monday’s FDA announcement said that between 2006 and 2013, five inspections at the company’s neuromodulation plant in Columbia Heights turned up violations of quality-control rules, resulting in three warning letters disclosing major violations in how the pumps are designed and made. “Defendants promised corrections at the conclusion of each inspection,” the FDA complaint says.

 

Medtronic, which moved its headquarters from Fridley to Ireland in January, has sold more than 230,000 of the devices worldwide since the first version was brought to market more than 25 years ago.

 

SOURCES: 

Star Tribune (Minneapolis, MN)
April 27, 2015
Joe Carlson

 

Star Tribune (Minneapolis, MN)
April 28, 2015
Joe Carlson