|
Model Number 5492VL |
Device Problem
Material Integrity Problem (2978)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/01/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that the patient cable failed to capture and pacing did not occur when in use with the external pulse generator (epg) connected to the patient post-operatively.It was noted that the issue was experienced when the epg was moved from the patient's chest to hang next to the bedside.It was further noted that the pacing wires were appropriately screwed into the lead ports.The patient was not pacing dependent and had a slow escape.The issue was experienced with ten patient cables in total with multiple epg's used.The customer switched to using different model patient cables which resolved the issue and pacing resumed.Upon further investigation, the customer considered that the weakness was near the strain relief portion of the patient cables with loss of connection in or near the socket.No patient complications have been reported as a result of this event.
|
|
Search Alerts/Recalls
|
|
|