D
Patient 1
A FORMER SUBJECT IN THE (B)(6) CLINICAL TRIAL (IDE G070025; SUBJECT (B)(6)) WAS ORIGINALLY CONVERTED TO A MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2015. THE SYSTEM, INCLUDING MODEL 2002 RECHARGEABLE NEUROREGULATOR, MODEL 2200A-47E ANTERIOR LEAD, AND MODEL 2200P-47E POSTERIOR LEAD WERE REPLACED ON (B)(6) 2016 (REFER TO MDR3005025697-2017-00005 THROUGH MDR3005025697-2017-00007 FOR DETAILS ON ORIGINAL RECHARGEABLE SYSTEM REMOVAL DUE TO EXCESSIVE MANIPULATION). ON APRIL 14, 2016, THE SITE REPORTED THAT ALERTS FOR LOW IMPEDANCE WERE EXPERIENCED AT FOLLOW-UP, NOTING THAT THE RING ELECTRODES WERE PLACED QUITE CLOSE TOGETHER AT IMPLANT. ON APRIL 21, 2016, IT WAS REPORTED THAT LOW IMPEDANCE MEASUREMENTS WERE AGAIN EXPERIENCED. RADIOGRAPH REVIEW SUGGESTED THAT THE RING ELECTRODES WERE IN VERY CLOSE PROXIMITY TO EACH OTHER WITH TWISTING OF THE LEADS NEAR THE NEUROREGULATOR. THE REPLACEMENT SYSTEM WAS EXPLANTED ON (B)(6) 2016. MDRS RELATED TO THIS ISSUE ARE: MDR3005025697-2017-00008: MODEL 2002 RECHARGEABLE NEUROREGULATOR, MDR3005025697-2017-00009: MODEL 2200A-47E ANTERIOR LEAD, MDR3005025697-2017-00010: MODEL 2200P-47E POSTERIOR LEAD.