Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 24-apr-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Information was received from an unknown source regarding a patient who was receiving lioresal (baclofen) (500 mcg per ml at 160 mcg per day) via an implantable pump for unknown indications for use.It was reported that the healthcare provider (hcp) noticed that the patients pump had been flipping since the last revision at cooks children's and the patient was scheduled for a pump revision on may 9.Upon arrival for the revision, it was decided by the physician and patient family that the pump would be moved to other side of abdomen and a new pump would be placed.The patients catheter was revised using a 8784 to opposite side of abdomen with the spinal segment remaining in use and new pump was placed on left side of abdomen.The issue was resolved at time of the report, patient status is alive no injury.
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