Medtronic unit halts defibrillator sales

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Medtronic unit halts defibrillator sales

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Medtronic's Physio-Control unit indefinitely suspended shipments of external

defibrillators and other emergency-response gear because of quality-control

problems at a factory in Redmond, Washington. The suspension will address

weaknesses in " the overall quality system " in the Redmond factory that were

identified by the U.S. Food and Drug Administration and the company,

Medtronic spokesman Rob said. The quality issues are related to

manufacturing processes and not any individual products, he said. No

products are being recalled. The halting of product shipments means that

Medtronic will delay the spinoff of Physio-Control as an independent public

company, which had been planned for mid-2007.

Medtronic did not fix defibrillator flaws

In a letter made public June 21, 2005, the U.S. Food and Drug Administration

warned Medtronic Emergency Response System, a unit of Medtronic, Inc., that

its failure to correct manufacturing problems or investigate complaints

regarding its LifePak 12 external defibrillators may force the company to

face civil and legal penalties. External defibrillators deliver powerful

electrical shocks to the chest in order to restore the heart's natural

rhythm.

The letter highlighted a problem with the LifePak 12 involving broken or

bent pins in therapy cables connected to the device, which is used to treat

patients experiencing sudden cardiac arrest. The damaged cables in some of

the LifePak 12 defibrillators caused them to deliver inappropriate energy

levels while in use, resulting in numerous complaints.

The FDA inspected Medtronic's plant in Redmond, WA, in February and March,

2005, on several occasions after Medtronic recalled about 87,000 units of

another implantable defibrillator after the discovery of battery failures.

At that time Medtronic promised to remedy manufacturing problems despite

citing an " internal analysis " of the LifePak 12, which they claimed revealed

no issues with the device. The recently published letter by the FDA states

that Medtronic has failed to adequately correct manufacturing problems

related to its defibrillators. The company also violated its own internal

safety procedures when it did not open an investigation on a defibrillator

complaint involving a patient death. The letter stated, " There have been

continued complaints of broken pins in the therapy cables used with the new

redacted connector " intended to remedy the flaw. The FDA pointed to

inadequate inspection procedures as one possible source of the problem.

Earlier this year, Medtronic recalled 1,924 LifePak 500 external

defibrillators due to 54 incident reports about a malfunction in the model

that caused the units to display a " connect electrodes " message even when

the device was properly connected. This flaw prevented patients from being

properly defibrillated. The Redmond facility in which they were manufactured

was previously owned by Physio-Control, a Washington company that first

commercialized the defibrillator. Manufacturing in the facility was shut

down for an entire year in 1992 after an FDA inspection raised questions

about its quality-control procedures.

FDA Shutdown in 1992

In 1992, Physio-Control voluntarily shut down production of its

defibrillators and patient monitors after a review by the U.S. Food and Drug

Administration found the company had failed to follow " good manufacturing

practices, " including inadequate failure investigations, not properly

inspecting critical components of its products, and failing to adequately

document manufacturing and testing procedures in writing.

Although the FDA never claimed that patients had been harmed by malfunctions

of the medical equipment, and no recalls were ordered, Physio-Control signed

a consent decree outlining steps it would take before resuming production.

O. , former vice president of business development who had

succeeded as president and chief executive in 1991, later told the

Puget Sound Business Journal that Physio-Control " truly, fundamentally

believed " that it was in compliance with all FDA requirements. He blamed the

sanctions on political pressure then being brought to bear on the FDA to

become more forceful in its interpretation of the rules.

Reaction

Fire Engineering EMS Editor Mike McEvoy said the Medtronic announcement is

reminiscent of the 18 month shutdown in 1992 after the FDA found the company

had failed to follow " good manufacturing practices. " With over 600,000

defibrillators and AEDs deployed in the United States, Medtronic Emergency

Response Systems controls some 70% of the US EMS market and nearly 50% of

the in-hospital market for external defibrillators.