Model Number L331 |
Device Problems
Failure to Capture (1081); Failure to Read Input Signal (1581); High Capture Threshold (3266)
|
Patient Problem
Complete Heart Block (2627)
|
Event Date 08/25/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to the description for more information regarding the specific circumstances of this event.
|
|
Event Description
|
It was reported that during a post-op device checkup, the pacemaker exhibited loss of capture in the right ventricular (rv) with a second-degree heart block.Review of the parameters showed that the auto threshold had increased to 5.0v at 0.4ms without maintaining capture.The rv pacing threshold was measured at 3.2v at 1.5ms bipolar.The atrial pacing threshold was at 2.5v at 1.5ms bipolar.Additionally, it was noted that the atrial lead measurements at implant showed high atrial thresholds at 3.2 at 1.5ms and low p waves sensing.The rv pacing thresholds was at 1.0v at 0.4ms.The rv outputs were programmed to auto threshold.The physician reprogrammed the device.The rv outputs were increased to an amplitude of 5.5v and pw of 1.5ms.The atrial outputs were programmed to 3.5v at 1.5ms.Furthermore, this patient was seen in the clinic a month after this event and both the atrial and ventricular pacing thresholds had improved in bipolar and were 0.3v lower in unipolar.Both the atrial and ventricular pacing vector were programmed to unipolar.This patient will continue to follow up with their health care professional (hcp).No additional patient effects were reported.This device remains in service.
|
|
Event Description
|
It was reported that during a post-op device checkup, the pacemaker exhibited loss of capture in the right ventricular (rv) with a second-degree heart block.Review of the parameters showed that the auto threshold had increased to 5.0v at 0.4ms without maintaining capture.The rv pacing threshold was measured at 3.2v at 1.5ms bipolar.The atrial pacing threshold was at 2.5v at 1.5ms bipolar.Additionally, it was noted that the atrial lead measurements at implant showed high atrial thresholds at 3.2 at 1.5ms and low p waves sensing.The rv pacing thresholds was at 1.0v at 0.4ms.The rv outputs were programmed to auto threshold.The physician reprogrammed the device.The rv outputs were increased to an amplitude of 5.5v and pw of 1.5ms.The atrial outputs were programmed to 3.5v at 1.5ms.Furthermore, this patient was seen in the clinic a month after this event and both the atrial and ventricular pacing thresholds had improved in bipolar and were 0.3v lower in unipolar.Both the atrial and ventricular pacing vector were programmed to unipolar.This patient will continue to follow up with their health care professional (hcp).No additional patient effects were reported.This device remains in service.
|
|
Manufacturer Narrative
|
This report is being sent for correction to field b2: outcomes attrib to adv event this product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to the description for more information regarding the specific circumstances of this event.
|
|
Search Alerts/Recalls
|