It was reported that device diagnostics resulted in high impedance.The patient was referred for surgery.It was later reported that during the surgery the pre-operative device diagnostics resulted in high impedance (>10,000 ohms).The device was interrogated and found to be programmed on to 2.25ma.There was an x-ray in the operating room that showed an obvious lead break.The surgeon dissected the electrodes off of the nerve and reimplanted a new generator and lead.Device diagnostics with the generator out of the pocket and in the pocket were both within normal limits.The new generator was left programmed off.It was reported that both the generator and lead were discarded in surgery; therefore no product analysis can be performed.
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