Model Number L331 |
Device Problems
Contamination (1120); Contamination /Decontamination Problem (2895)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/22/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
The device will be returned for analysis.Upon return and analysis completion this investigation will be updated.
|
|
Event Description
|
It was reported that during a follow up high pace impedance measurements were exhibited on this right ventricular (rv) lead as well loss of capture.A revision took place as a result and a lead fracture was seen, thus this lead was explanted and will be returned.When placing a new electrode with this device evidence of a corroded and oxidized zone in the area of the header was seen, thus the device was also replaced and will be returned.No adverse patient effects were reported.
|
|
Event Description
|
It was reported that during a follow up high pace impedance measurements were exhibited on this right ventricular (rv) lead as well loss of capture.A revision took place as a result and a lead fracture was seen, thus this lead was explanted and will be returned.When placing a new electrode with this device evidence of a corroded and oxidized zone in the area of the header was seen, thus the device was also replaced and will be returned.No adverse patient effects were reported.
|
|
Manufacturer Narrative
|
The device was expected to be returned for analysis.Upon return and analysis completion this investigation will be updated.
|
|
Event Description
|
It was reported that during a follow up high pace impedance measurements were exhibited on this right ventricular (rv) lead as well loss of capture.A revision took place as a result and a lead fracture was seen, thus this lead was explanted and will be returned.When placing a new electrode with this device evidence of a corroded and oxidized zone in the area of the header was seen, thus the device was also replaced and will be returned.No adverse patient effects were reported.Additional information noted that there was no issue with device l331/923437 and the device remains implanted.Additional information regarding device l331/924236 can be reviewed in report 14937485.
|
|
Search Alerts/Recalls
|