Model Number 1258T/75 |
Device Problems
Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438)
|
Patient Problems
Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)
|
Event Date 06/26/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Further information was requested but not received.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
|
|
Event Description
|
It was reported that a loss of pacing and episodes of oversensing due to electromagnetic interference was noted.This resulted in the pacemaker dependent patient receiving an inappropriate shock.Furthermore, high out-of-range pacing impedance values were noted on the left ventricular lead.Lead revision is anticipated.Manufacturer reported number: 2938836-2019-05798.
|
|
Event Description
|
Additional information received indicating that during the lead revision, insulation damage was noted on the left ventricular lead.The lv lead was capped and replaced to resolve the event.The patient was stable with no consequences.Manufacturer reported number: 2938836-2019-05798.
|
|
Search Alerts/Recalls
|