Model Number U125 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Unspecified Infection (1930); Sepsis (2067); No Code Available (3191)
|
Event Date 06/18/2020 |
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.(b)(4).
|
|
Event Description
|
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was part of a system revision due to infection with sepsis.There were no additional adverse patient effects reported.The crt-p was explanted.
|
|
Manufacturer Narrative
|
Patient code 3191 captures the reportable event of surgery.Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the allegation against the device was not confirmed.The device was analyzed, passed all the baseline tests and exhibited normal device functions.This supplemental is being filed to capture the return date and the product investigation results.
|
|
Event Description
|
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was part of a system revision due to infection with sepsis.There were no additional adverse patient effects reported.The crt-p was explanted.
|
|
Search Alerts/Recalls
|