Potential Fractured Power Supply Wires
Kappa 600, 700 Dual Chamber (D, DR, and VDD) IPGs
Original Date of Advisory:
A specific subset of Kappa 700/600 dual chamber (D, DR, and VDD) implantable pulse generators has been identified by serial numbers. Hospitals and Physicians were notified. You may use the "Search for Information by Serial Number" tool on this web page to determine if a specific device is affected.
As of March 15, 2002, Medtronic observed 53 related failures (0.02%) in over 255,000 Kappa 700/600 dual chamber (D, DR, and VDD) series devices sold worldwide. Medtronic voluntarily communicated this information to physicians because these failures had been observed in patients having submuscular implants.
These devices have presented with an electrical reset, intermittent output, or no output. Our investigation identified the root cause as fractured wires supplying power to the pacemaker. This has been directly correlated to submuscular placement of these devices. Submuscular implant locations (e.g., subpectoral, abdominal, etc.) can result in additional stress and repetitive flexing on the implanted device causing excessive fatigue on these wires. Of the estimated 4,000 devices implanted submuscular, approximately 200 (5%) may experience this failure. These stresses on the implanted device are unique to submuscular implant sites and do not exist with subcutaneous implants.
Patient Management Recommendations
While there is no provocative testing or time dependency that will predict which submuscular placed device will fail, certain electrical resets may be an indicator that a wire fracture has occurred. Normal electrical resets can occur as a result of electrosurgical procedures such as cautery and ablation or from defibrillation therapy. If none of the normal causes of electrical reset can be confirmed, or if a device serial number presents as “000000” following an electrical reset, this may be an indicator of a wire fracture.
For patients who have submuscular implants of devices within the designated serial number range and who are pacemaker dependent with no underlying rhythm, replacement of the device should be considered. Medtronic will provide the replacement device free of charge under the terms of its warranty program if a device is replaced in these patients.
For patients having subcutaneous implants, no change to your current patient care and follow-up is advised.
Patient management recommendations remain unchanged. As of February 27, 2012, three hundred thirty-seven (337) out of approximately 180,000 distributed (0.18% incidence) Kappa family devices worldwide have been confirmed as having fractured power supply wires. One hundred seventy (170) of these devices were returned from the United States. Out of the initial implant population of 121,000 in the United States, less than 500 remain implanted.
|Initial Affected Population||Number of Confirmed Advisory Related Events||Estimated Remaining Active Population||Current Malfunction Rate (confirmed malfunctions over total population)||Predicted Malfunction Rate Over the Remaining Life of the Devices Still Implanted|
180,000 Active worldwide at the time of the advisory (121,000 United States)
337 Worldwide (170United States)
<500 Worldwide (<500 United States)
0.19% Worldwide (0.14% United States)