Model Number K063 |
Device Problems
Signal Artifact/Noise (1036); High impedance (1291)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/11/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that this implantable pacemaker exhibited noise and high out of range pacing impedance measurements on the right ventricular channel.Due to this a lead safety switch was triggered.Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.
|
|
Manufacturer Narrative
|
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the complaint description for more information regarding the specific circumstances of this event.
|
|
Event Description
|
It was reported that this implantable pacemaker exhibited noise and high out of range pacing impedance measurements on the right ventricular channel.Due to this a lead safety switch was triggered.Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.
|
|
Search Alerts/Recalls
|