Correction: this regulatory report is a correction report of regulatory report #3007566237-2019-00820.The issue occurred on this device, and there was no issue with the device listed in regulatory report # 3007566237-2019-00820.All future regulatory reports will follow up under this regulatory report submission.If information is provided in the future, a supplemental report will be issued.
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Information was received from a manufacturer representative (rep) and confirmed by the physician regarding a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome.It was reported that on (b)(6) 2019, the rep went to an ins replacement (no device issue was reported) and in pre-op they tested impedances on the new ins with the following programming: -0 3+, -4 7+, 210 us, 30 hz.It was noted the patient's programming was only using contacts 0, 3, 4 and 7.The impedance readings were the following: 0,1 ???; 0,2 1442; 0,3 1442; 0,4 1442; 0,5 ???; 0,6 1442; 0,7 1442; 1,2 714; 1,3 1442; 1,4 1442; 1,5 714; 1,6 1442; 1,7 1442; 2,3 ???; 2,4 ???; 2,5 714.It was noted the impedances also had "<(><<)>15" after them.No symptoms were reported.The rep confirmed they would not be using contacts that appeared with "???" in the impedance reading, so they were not concerned about that, and explained the patient would be using the same program.Technical services explained that the ??? appeared due to a software issue, and that the impedances used in the patient's programming were within normal range.It was also suggested the rep check impedances again after increasing pulse width and then to test at 3 volts or 4 volts.After increasing pulse width and increasing the voltage to 3v or 4v, the impedances still did not resolve, however it was confirmed that the patient was receiving effective therapy.No further complications were reported or anticipated.
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