Model Number 8145 |
Device Problems
Failure to Conduct (1114); Migration (4003)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 01/29/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that the patient had not received optimal therapy since device activation.Initial investigation and review of the post-initial implant images revealed the surgeon placed the lead too far from the target area.The revision surgery was scheduled to replace both leads.During the revision surgery, difficulties were encountered during the extraction of the right lead due to resistance and kink at the loop location, resulting in the lead fracture of the right lead.All pieces were removed.The event was attributed to poor implant technique.The left lead was removed with no issues.Two new leads were implanted with no reports of patient harm or injury.The surgeon was re-trained on proper lead implant techniques and lead positioning.Following the lead revision, the reactiv8 system was activated by programming the reactiv8 ipg to allow the patient to initiate bilateral stimulation.
|
|
Manufacturer Narrative
|
Mml reference #: (b)(4).
|
|
Manufacturer Narrative
|
Mml reference #: (b)(4).The device was received and evaluated.No problem was identified that could contribute to the suboptimal lead placed/migration.The leads were replaced due to poor placement by the surgeon.
|
|
Event Description
|
It was reported that the patient had not received optimal therapy since device activation.Initial investigation and review of the post-initial implant images revealed the surgeon placed the lead too far from the target area.The revision surgery was scheduled to replace both leads.During the revision surgery, difficulties were encountered during the extraction of the right lead due to resistance and kink at the loop location, resulting in the lead fracture of the right lead.All pieces were removed.The event was attributed to poor implant technique.The left lead was removed with no issues.Two new leads were implanted with no reports of patient harm or injury.The surgeon was re-trained on proper lead implant techniques and lead positioning.Following the lead revision, the reactiv8 system was activated by programming the reactiv8 ipg to allow the patient to initiate bilateral stimulation.
|
|
Search Alerts/Recalls
|