Model Number 479888 |
Device Problems
Retraction Problem (1536); Activation, Positioning or Separation Problem (2906)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/12/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that during the implant procedure, the lead was placed using the guidewire.After the lead was placed, the guidewire could not be removed from the lead.The lead was not used and a new lead was implanted using a new guidewire.No patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
The full lead was returned and analyzed.The analysis indicated that the stylet/guide wire was analyzed and was stuck in the lead due to a knot at the end of the guide wire.The outer insulation of the lead was observed to have blood ingression.The analyst noted that the blood ingression which is normal for this model lead contributed to the guide wire being stuck in the lead.The guide wire has a knot at the distal end of the guide wire.The guidewire test was not performed due to an existing guidewire stuck in the lead.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
This lead is investigation and should not have been reported.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|