FDA cites Medtronic drug pump's severe flaw

  • Article by: WENDY LEE , Star Tribune
  • Updated: September 12, 2011 - 9:48 PM

The company had alerted regulators in July about problems with the SynchroMed II pump.

Federal health officials said Monday that an implantable drug pump that Medtronic Inc. recalled this year had a potentially life-threatening design problem.

The pump, called the SynchroMed II, delivers drugs directly into the spinal fluid to treat chronic pain and spasticity. The problem relates to the formation of a film within the pump's battery that could hurt the battery's performance and stop the therapy.

Fridley-based Medtronic recalled the product in July, notifying the Food and Drug Administration, patients and doctors about the issue. At the time, the problem had arisen in 55 cases, including one death due to drug withdrawal, among 139,653 SynchroMed II pump implants worldwide.

The FDA on Monday classified the recall as Class I, which refers to products that have a "reasonable probability" of causing "serious adverse health consequences or death."

Medtronic spokeswoman Donna Marquard said the FDA granted Medtronic approval for a new battery design for the implantable pump in July that corrects the problem. Ten days after receiving FDA approval, the company started shipping pumps with the new battery design, she said.

The changeover has already been implemented in Europe, Australia, New Zealand, Canada, Africa and India, Marquard said.

Patients with pumps that lack the new design are advised to alert their physicians if their device alarms or if they experience a return of symptoms. The problems occurred 45 to 78 months after the implant in the confirmed cases, Medtronic said.

Debbie Wang, a medical device analyst with Morningstar, said she doesn't expect that the recall will have an impact on Medtronic's overall performance. But Wang said that if more recalls occur at a continuous pace, it may raise other concerns.

"Anytime you get one of these recalls, it's a little nerve-wracking because you wonder if it's a signal if this company is slipping and cutting corners or not paying close enough attention on quality," Wang said. "I don't see any indication of that yet with Medtronic, but it's a question that I ask."

Wendy Lee • 612-673-1712

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