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Model Number 8637-20 |
Device Problems
Volume Accuracy Problem (1675); Device Or Device Fragments Location Unknown (2590); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8731sc, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2017, product type: catheter.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), (b)(6), (b)(4).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 consumer regarding a patient who was receiving clonidine, unknown concentration at 0.349 mg/day dose, bupivacaine, unknown concentration at 0.2499 mg/day dose and dilaudid, unknown concentration at 0.5 mg/day dose via intrathecal drug delivery pump for non-malignant pain.It was reported that volume discrepancy occurred.The patient did not know volume information.In (b)(6) 2017, the patient was seen for routine refill.At that time a volume discrepancy was noted.Two weeks later, the patient had a procedure to redo the catheter.The catheter was "pinched or broken" and the tip of the catheter had broken off into the intrathecal space and was not retrievable/not found.The consumer also said that the "last pump failed" but it was a catheter issue that caused the volume discrepancy but pump and catheter were replaced on (b)(6) 2017, likely this could be due to 7 year pump longevity.No further complications were reported.
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Search Alerts/Recalls
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