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Medtronic LIFEPAK Defibrillators Quality Control System Issues Revealed

Filed May 7th, 2008 amy

Medtronic’s Physio-Control Inc suspended shipments of of its LIFEPAK defibrillators in January 2007, citing vague “quality control system issues.” But court documents filed last week shed a little more light on what Medtronic is hiding. The FDA’s injunction against Medtronic and Physio-Control cites 11 violations, reported by FDA inspectors during a 2006 visit.

These violations include:

  • Failure to investigate complaints involving the possible failure of a device to meet any of its specifications.
  • Failure to submit a written report to FDA of a correction or removal of a device initiated by manufacturer or importer to reduce a risk to health or to remedy a violation of the (Federal Food, Drug, and Cosmetic Act).
  • The FDA concluded based on the violations that Physio-Control’s defibrillators were both “adulterated” and “misbranded.” The regulatory body also said that many of the violations were similar to violations discovered in 1992, 2000, 2003, and 2005.

Per court documents filed earlier this year, the FDA re-inspected the Redmond plant and found that there continued to be violations.

The Seattle PI blog reports that according to the agreement reached between the FDA and Physio-Control last week, also filed in United States District Court, Physio-Control is banned from selling defibrillators until the company complies with the Federal Food, Drug, and Cosmetic Act and hires an independent expert to conduct inspections, among other remedies.

It is unclear exactly how long it will take Physio-Control to comply with the agreement, at which point it will again be able to sell its defibrillators. However, if Physio-Control does not comply with the agreement it will have to pay a fine of $15,000 per day, in addition to $15,000 per day for each violation.

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