Model Number 4513 |
Device Problems
Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Unspecified Infection (1930); Perforation (2001); Pocket Erosion (2013)
|
Event Date 04/20/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
|
|
Event Description
|
Boston scientific received information that this left ventricular (lv) lead was part of a system revision due to infection and erosion.Reportedly, the device was infected with the lead perforation through the skin and open wound.The patient was given intravenous antibiotics preoperatively.The device pocket was debrided and cauterized for potential bleeding sites.The wound was then debrided and irrigated with antibiotic saline solution.There were no additional adverse patient effects reported.The lv lead was explanted.
|
|
Event Description
|
Boston scientific received information that this left ventricular (lv) lead was part of a system revision due to infection and erosion.The patient was given intravenous antibiotics preoperatively.The device pocket was debrided and cauterized for potential bleeding sites.The wound was then debrided and irrigated with antibiotic saline solution.The lv lead was explanted.No additional adverse patient effects were reported.
|
|
Search Alerts/Recalls
|