During the generator repositioning surgery for lead extrusion reported in mfg report #1644487-2018-02130, it was noted during the surgery that just below one of the lead pins, scar tissue had formed in the shape of a tube around the pin's wire.It was stated that within the tube, the lead wire had a portion that was exposed with the insulation pulled back.Diagnostics were performed outside the pocket noting impedance within normal limits.The generator was then positioned and secured into the pocket.Another diagnostic was performed with ok impedance and the pocket was closed.No additional relevant information was received to date.
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It was stated that the patient had a battery replacement on (b)(6) 2017, and the surgeon went back into the chest pocket in (b)(6) 2018 to attempt to correct an infection.No replacement occurred.It was stated that now the patient has an infection that has "erupted" above the generate site, not at the incision site.The physician was planning to remove the lead and generator.It was confirmed that the generator and lead were explanted due to the infection.No device was to be returned for analysis.No device was received to date.No additional, relevant information was received to date.
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