MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Kinked (1339); Unstable (1667); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2018, udi#: (b)(4), implanted: (b)(6), product type: catheter.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare provider (hcp) and an hcp via a manufacturer representative regarding a patient who was receiving dilaudid (10mg/ml at 5.4mg/day) via intrathecal drug delivery pump.The indication for use was noted as non-malignant pain.It was reported that the pump had been flipping a lot and the patient said it was flipping all the time.This resulted in kinks in the tubing.The pump was manually flipped back on (b)(6) 2018 and a catheter revision was completed on (b)(6) 2018, where a portion of the catheter was replaced.The portion of this item that was accessible in the pump pocket was found to be twisted repeatedly.No environmental, external, or patient factors were reported to have caused this issue.During the catheter revision, the pump was resutured to the fascia.The issue was said to have been resolved and the patient was "alive - no injury." no symptoms were reported.There were no further complications reported at this time.
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Search Alerts/Recalls
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