The Heart Rhythm Society Device Performance Recommendations has urged the Food and Drug Administration (FDA) to develop a more robust system that overcome many of the MAUDE database shortcomings and strengthen the voluntary reporting system of unanticipated medical device problems.

In response, FDA launched a new MedSun adverse event reporting subnetwork called HeartNet that allows participants with EP labs to report adverse events through a specialized data collection tool. Devices of interest include:

• ICDs, pacemaker and ICD leads,
• RF ablation therapy devices,
• ablation catheters and generators,
• EP electro-anatomic mapping systems, among other devices.

Learn more about Heartnet:

• Download the HeartNet factsheet (PDF, 69K)
• Current information (provided By FDA through HeartNet, including abstracts and recall information)