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Medtronic Gets FDA Warning After Inspection

Posted by Jane Akre
Wednesday, November 18, 2009 11:02 AM EST
Category: Major Medical
Tags: Defibrillator, ICDs, Medtronic, FDA, Heart Disease

Medtronic ICD has problems with production notes the FDA after an August inspection.


IMAGE SOURCE: Medtronic Web site/ Medtronic Sprint Fidelis lead

FDA Inspection Finds Problems

Medtronic, the maker of medical devices that corrects heart rhythms, has been ordered to fix problems at its Minnesota factory following a Food and Drug Administration (FDA) inspection at its manufacturing plant.

The company received a warning letter from health regulators to take immediate action, though the company didn’t detail the FDA’s concerns uncovered during the August inspection at its Mounds View, Minnesota facility.

The heart implants division makes cardiac rhythm disease implants, including pacemakers and other surgically implanted medical devices that slow or stabilizes the heart beat, reports AP.

The Wall Street Journal reports that the problems fall into four general categories - corrective and preventive action and field-action timeliness; review and documentation of field-action recommendation; supplier qualification; and control and medical-device reporting timeliness.

So far this year, Medtronic has issued two recalls – one a wiring defect in pacemakers in May. In July it recalled some defibrillators that were malfunctioning in the presence of humidity. 

These were noted to be Class I recalls, a FDA designation that is the most serious putting patients at risk of injury or death.

In April, Medtronic’s Sprint Fidelis cardiac wire was implicated in more than the five deaths the company previously revealed after an independent panel of physicians said the count is closer to 13.

The wire, attached to a defibrillator, was in the heart of some 270,000 patients when Medtronic stopped making the defective product in October, 2007. At that time the company estimated five people might have died as a result of its malfunction.

There are about 2,200 reports of serious injuries from the lead, reported to the Food and Drug Administration.

The company released information about the increased number of deaths after a federal judge earlier this year dismissed more than 700 consolidated cases charging product liability, negligence, fraud, and breach of contract, among others against Medtronic, filed in U.S. District Court in Minnesota.

Judge Richard Kyle, cited last year’s Riegel decision in dismissing the lawsuits. In Riegel, the U.S. Supreme Court ruled in favor of medical device makers affirming they enjoy a shield since their products have FDA approval.

The company has 15 days to respond to the latest problems and says it has already started to implement changes.

Medtronic stock was recently down 15 cents at $40.05 in premarket trading, though is up 28 percent so far this year. #

1 Comment

Anonymous User
Posted by JILL PAUL RN
Thursday, November 19, 2009 5:25 PM EST

Jane, thank you for bringing this to our attention. Just one more reason why it is crucial that The Medical Device Safety Act 2009 needs to be passed now to prevent further injury and suffering to patients' receiving inferior medical products. Thank you.

Comments for this article are closed.

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