Had medtronic intrathecal baclofen pump implanted (b)(6) 2012, replaced (b)(6) 2019 without incident for end of life, filled with 40ml of 2gm/ml solution (gablofen from piramal).Had rate increase (b)(6) 2019.With increase rate from 175 mcg/d to 185mcg/d.Returned (b)(6) 2019 for refill of pump at 6 month interval, reported mildly stiffer.Found 39.5 ml in pump (40 ml reservoir); pump computer calculated should be 23.7ml.Logs report no malfunction, no alarms triggered.Xray showed no systems defects.Pump replaced (b)(6) 2019, system appeared intact.Pump returned to medtronic, evaluation report received later of no defect found, so remain with no explanation for the pump failure to deliver medicine which should have emptied the reservoir.Fortunately, patient¿s apparent withdrawal was mild.Improved with new pump.Fda safety report id # (b)(4).
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