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13,440 pacemakers recalled due to software error (February 2019) (fda.gov)
1 point by s1512783 on May 9, 2019 | hide | past | favorite | 1 comment



Medtronic's letter to clinicians contains more details on the issue: https://www.medtronic.com/us-en/healthcare-professionals/pro...

"For this error to occur, a unique combination of events must take place while the device is processing an atrial-sensed event. If this error occurs, the device will be unable to provide pacing until a ventricular-sensed event (VS) is detected. Once a VS is detected, normal pacing functionality is restored immediately. If a VS is not detected, the device will withhold both atrial and ventricular pacing. In addition, until a VS is detected, the device will be unable to initiate a session with a programmer, initiate a session with a CareLink™ remote monitor, or respond to a magnet. "




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