Block b3: exact date unknown, event occurred between (b)(6) 2019.Additional suspect medical device component involved in the event: product family: dbs-extension, upn: m365nm3138550.Model: nm-3138-55, serial: (b)(6), batch: 7034124; product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7045710.
|
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure to remove the implantable pulse generator (ipg) and two extensions due to infection.The physician would not release any further information or details regarding the event.Boston scientific representatives were not present at the explant procedure; therefore, the devices could not be returned, and physical analysis could not be conducted in our laboratory.
|