Medtronic Safety Warnings

 

 

 

In this section:

• Medtronic Products
• Medtronic Safety Warnings
• Medtronic FDA Recall

As a developer and manufacturer of cardiovascular medical devices, Medtronic are responsible for releasing safety warnings regarding defects associated with their various product lines.

Cardiovascular medical device defects can be somewhat commonplace; however, not all defects warrant the issuing of a recall. A Medtronic recall is only issued when a defect is expected to put large numbers of patients at risk. I.E, when a product is found to have a significantly higher-than-expected failure rate. The following advisories represent a mere handful of the safety warnings issued by Medtronic Inc. throughout the years.

Medtronic Pacemaker Safety Warnings

Sigma Series (100, 200, and 300)

September 27th, 1999 - An initial safety warning was first issued in regards to the Sigma Series pacemaker pulse generators well before the device's recent recall. The initial safety warning was issued because a defect was discovered that was capable of causing the sudden loss of sensing or pacing output. The issue was thought to be tied to a specific manufacturing flaw and therefore limited to a minimal number of specific devices.

November 29th, 2005 - Another Sigma Series defect this time lead to the issuing of a Medtronic pacemaker recall. The defective Medtronic pacemakers demonstrated wiring problems that were causing devices to fail. Although there were only 19 defective Medtronic pacemakers out of 40,000 devices implanted worldwide, the failure rate was higher than expected. The problem was caused by the use of a particular wire-cleaning solvent. Over time, this solvent caused the wiring to degrade, culminating in device failure. Defective Sigma Series pacemakers represent the most recent Medtronic recall; there are an estimated 28,000 implanted Sigma Series pacemakers remaining in patients around the world.

Kappa 600 Dual Chamber (D, DR & VDD)

March 15th, 2002 - Of the 255,000 Kappa 600 / 700 dual chamber (D, DR & VDD) devices implanted in patients around the world, there have been a total of 53 related failures. Although the 53 failures only represent .02% of the Kappa pacemakers in circulation, the relationship between the defects lead to Medtronic's issuing of a safety warning. Thus far, there have been no reports of device failures causing serious injuries or death. The defect has only been observed in patients having submuscular implants; the defect was viewed to be directly related to the submuscular placement of the pulse generator (subpectoral / abdominal). The location of the submuscular Kappa 600 pacemakers were shown capable of placing extreme levels of stress on the device and corresponding wires, causing fractured wires that resulted in electrical resets, intermittent output or no output at all. Medtronic believed that of the 4,500 submuscularly implanted Kappa pacemakers, approximately 5% would experience some type of failure.

Medtronic ICD Safety Warnings

Marquis DR Model 7274 ICD

February 2005 - A Medtronic safety warning was issued regarding Marquis DR Model 7274 ICD devices because of a rapid battery depletion defect that was detected in models manufactured prior to December of 2003. The rapid battery depletion was tied to an internal battery short mechanism. Although only affecting one in every 10,000 (.01%) Marquis devices in the first half of device life, occurrences of the defect were shown to increase to between .2% and 1.5% over the second half of device life. Without battery power, ICD devices are unable to generate the shocking power required to stave off instances of tachycardia.

Micro Jewell II Model 7223Cx ICDs

April 5th, 2004 - A safety warning regarding the Medtronic Micro Jewell II Model ICD device was intended to supplement previously issued safety letters (August 1999 and November 2000). The 2004 safety warning was in regards to battery defects that were preventing the devices from providing patients with a full-energy shock. The defect is caused when battery voltage is below 5.13 V and has been shown to affect less than .5% of the Micro Jewell II devices currently implanted in patients.