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Home > Performance Notes

Potential Malfunction Of CRT, ICD And IPG Products Due To Anomalies In MOSFET Integrated Circuit Technology.

Medtronic has detected a specific pattern of MOSFET IC malfunctions in its Concerto®, Virtuoso® and EnRhythm® family of devices. As of July 2009, Medtronic has confirmed twenty-eight (28) malfunctions related to this pattern out of 115,000 EnRhythm and 233,000 Concerto®/Virtuoso® products distributed worldwide. Reliability analysis of this pattern shows the probability of occurrence decreases with time and, to date over 90% of the malfunctions related to the pattern have occurred within the first twelve months after implant. With process improvements in place, Medtronic expects few, if any, additional malfunctions related to this pattern.

The pattern involves metal–oxide–semiconductor field-effect transistors (MOSFET). A MOSFET is an electronic circuit used to amplify or switch electronic signals. MOSFETs have been used in the electronics industries for decades and MOSFET technology is the most widely used type of integrated circuit. Medtronic uses this technology in the circuitry of its CRT, ICD and IPG products. Each product contains thousands of MOSFETs in its electronic circuitry.

Each MOSFET depends on a layer of insulating material to electrically isolate its components. The integrity of this insulating layer is important to the operation of the MOSFET. Variation in the thickness of the insulating layer can cause the MOSFET to operate in an undesirable manner. Process variations for electronic circuits can affect the integrity of the insulating material, and can lead to MOSFET malfunction. Medtronic's quality system strives to control process variation and detect undesired anomalies that are characteristic of all MOSFET manufacturing. In addition, Medtronic's post market vigilance activities monitor malfunctions and may implement screening and testing improvements when a pattern of related malfunctions is identified.

The pattern with the Concerto®, Virtuoso® and EnRhythm® models has presented clinically as high lead impedance, sensing difficulty, loss of pacing therapy and/or early battery depletion due to higher than normal battery drain. The degree of battery drain varies case by case, such that the time from the onset to battery depletion has ranged from several days to several months. If not detected by normal patient follow up procedures, the use of patient alerts or CareLink® remote monitoring, the battery will fully deplete, leaving the patient without therapy.

As of March 2009, Medtronic has implemented additional electrical screening and stress tests to address this specific pattern for products being sold.

Since these rates of malfunction are low and the probability of occurrence decreases with time, Medtronic recommends physicians continue following patients in accordance with standard practice.