It was reported that device diagnostics resulted in high impedance (>10,000 ohms) on (b)(6) 2014 and again on (b)(6) 2014.It was reported that x-rays did not show an obvious lead break.It was reported that device diagnostics during generator replacement in (b)(6) 2013 were within normal limits (2640 ohms).There was no trauma or patient manipulation that is believed to have caused or contributed to the high impedance.X-rays were sent to manufacturer for review.Review of x-rays identified that the lead pin did not appear to be fully inserted into the generator header.Clinic notes dated (b)(6) 2014 note that device diagnostics showed impedance value - >10,000 ohms.It was noted that the patient suffered a bad fall approximately one months prior and that the patient has a tendency of striking his fists against his upper chest.The patient also uses his fingers to tug on his clavicles.It was noted that any of these activities may have dislodged the lead pin or produced a fracture in the lead.The patient was referred for surgery.During surgery, the lead pin was removed and then reinserted into the generator header.Device diagnostics were then within normal limits.The high impedance is related to the lead pin not being fully inserted into the generator header.
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