Prior to (b)(6) 2021 the battery checker read 3.30 and 3.80, seen neurologist on (b)(6) 2021 he states he was just deleting old settings see medical record all documented/recorded for referencing dr states battery is good so does other 2 people in room, deleted old settings but everything checks out, in 13 days the battery depleted, have pics, never could change settings myself (documented) tremors seem to worsen checked the battery it was at 7.90 and 9.00 as the battery checker stated we have never changed settings or changed settings as we have never had to the checker has always been on 3.30 and 3.80 when checked as i documented everything.Tremors worsened and on (b)(6) 2021 the eri light came on.A medtronic rep interrogated the system and had to put it back to 3.30 3.80 explaining that they can only use the settings programmed by the clinician.The battery worked fine until (b)(6) 2021 mid evening the tremors seem to pick up contacted the clinic.On (b)(6) 2021 the hospital put a new battery in a percept pc different setup from before but now this one seems to create more tremoring can't check the settings in percept pc as documented by medtronic, also a representative also came out and a staff member made a recording on how to check it if needed as the rep stated.The 7.90 and 9.00 setting should not be used.Also the percept pc needs to be addressed.Have videos, records, logs, all documented.Contact with the (b)(6) (mdhhs also viewed documentation from medtronic) contacted medtronic documented stating not mri mode.Ipg is implanted only have pic of dbs checker settings, never changed, documented only a physician can change settings.Prior to appt a medtronic rep stated a different mode but i called medtronic headquarters and they gave me documented confirmation that the rep was wrong.New ipg doesn't work like other one.Fda safety report id# (b)(4).
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