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Model Number 8637-40 |
Device Problems
Fluid/Blood Leak (1250); Kinked (1339); Aspiration Issue (2883)
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Patient Problem
Pain (1994)
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Event Date 03/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8637-40, serial# (b)(4), implanted: (b)(6) 2014, product type: pump.Other relevant device(s) are: product id: 8637-40, 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 healthcare provider via a clinical study regarding a patient receiving hydromorphone (10.0 mg/ml at 2.0 mg/day), fentanyl (1515.0 mcg/ml at 310.0 mcg/day), and bupivacaine (9 mg/ml at 1.8 mg/day) via an implanted pump.The indication for use was spinal pain.It was reported the patient's pain was more intense compared to the pain they had previously had.It was noted the change was due to a fall.No environmental factors were contributing to the loss of pain control.A catheter dye study was performed, on (b)(6) 2018, and a leak was detected.It was noted the pump originally didn't aspirate and only when manipulated did fluid start to come out.There was also a leak at the anchor site at l1 with intrathecal contrast noted.A kink was found at the collette.It was indicated the event was possible related to the device or therapy and unlikely related to the implant procedure.The device diagnosis was catheter leakage and the clinical diagnosis was increase in pain.The patient's catheter was explanted and not replaced on (b)(6) 2018.It was noted the catheter was returned to the manufacture.The issue resolved without sequelae on (b)(6) 2018.It was noted the patient was also taking hydrocodone, keflex, mvi, omepreazole, sertraline, vistaril, wellbutrin at the time of the event.The patient's medical history included post laminectomy syndrome, sleep apnea, arachnoidits, seizure disorder, depression.The patient's weight was noted as (b)(6).
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Manufacturer Narrative
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Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from healthcare provider (hcp) via clinical study indicated the catheter was explanted and replaced on (b)(6) 2018.No further complications were reported/anticipated.
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Manufacturer Narrative
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The catheter was returned, and analysis found a kink in the catheter body and a hole-not user related in the catheter body.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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