Model Number 1192 |
Device Problem
Break (1069)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 05/26/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event is estimated.
|
|
Event Description
|
Related manufacturer report 3006705815-2021-02831.Related manufacturer report 3006705815-2021-02822.Related manufacturer report 1627487-2021-15181.It was reported that upon x-ray review visible lead fracture at the anchor site was observed.Patient experiences frequent falls.During the procedure anchor breakage was confirmed.Patient experiences frequent falls.Both leads and anchors were explanted.Patient was stable.
|
|
Manufacturer Narrative
|
The reported event for break was confirmed.As received, both swift-lock anchors had the distal end broken off.The broken distal end is consistent with overstress condition the anchors may have been subjected to while in vivo.
|
|
Search Alerts/Recalls
|