Model Number 4671 |
Device Problems
Positioning Problem (3009); No Apparent Adverse Event (3189)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/27/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that this left ventricular (lv) lead was a case of an attempted implant due to product performance issue.This lead was replaced and never in service.No adverse patient effects were reported.
|
|
Manufacturer Narrative
|
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
|
|
Event Description
|
It was reported that this left ventricular (lv) lead was a case of an attempted implant due to product performance issue.This lead was replaced and never in service.No adverse patient effects were reported.Additional information received indicated that this lv lead was attempted due to patient anatomy.No adverse patient effects were reported.
|
|
Manufacturer Narrative
|
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
|
|
Manufacturer Narrative
|
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.Upon receipt at our post market quality assurance laboratory, an evaluation of this lead was performed.The difficult to position allegation was not confirmed.Visual inspection found no evidence to support lead placement difficulty.Blood in the lumen of an open tip lead is considered evidence that implant was performed or attempted.It is not evidence of device damage, defect or malfunction.
|
|
Event Description
|
It was reported that this left ventricular (lv) lead was a case of an attempted implant due to product performance issue.This lead was replaced and never in service.No adverse patient effects were reported.Additional information received indicated that this lv lead was attempted due to patient anatomy.No adverse patient effects were reported.
|
|
Search Alerts/Recalls
|