It was reported that during generator replacement the lead showed uninsulated spot just after the connection to the generator.Furthermore, the lead was bent 180 degrees at this spot.The lead was disconnected from the old generator with some difficulties.Then, it was plugged in the new generator.The lead impedance at this time was 1400 ohms.Generator was placed into the pocket, and the wound was closed.System diagnostics was performed again and it showed impedance below 600 ohms.New generator has been left in place.Follow up indicated that no explanted generator return is possible as this was discarded after the replacement surgery.It was also reported that the physician did not suspect a lead manipulation.The device manufacturing records were reviewed.The review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.Further follow up with nurse indicated that the patient underwent a lead and generator replacement; during the lead replacement on (b)(6) 2016 no hex screwdriver was available in the or to disconnect the lead from the generator.That was the reason of the replacement of the generator as well.The facility will not return the explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
|