MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Occlusion Within Device (1423)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 02/23/2018 |
Event Type
Injury
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Manufacturer Narrative
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The main component of the system and other applicable components are: product id: 8709sc, lot#: n207028001, implanted: (b)(6) 2009, product type: catheter.Product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2015, 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 manufacturer representative via a patient who was receiving morphine (20 mg/ml, 4.798 mg/day) via in trathecal drug delivery pump for spinal pain.It was reported that the patient was experiencing withdrawal symptoms and was unaware that they were withdrawal symptoms.There were no known environmental, external or patient factors that may have led or contributed to the issue.A catheter dye study was performed on (b)(6) 2018 and the catheter was occluded.A revision surgery was scheduled for (b)(6) 2018.The issue was not resolved and the patient status was "alive - no injury" at the time of this report.No further complications were reported.
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Manufacturer Narrative
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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 was received from the healthcare professional via manufacturer representative.It was reported that the revision surgery was performed as planned, and the catheter was not sent to the manufacturer for analysis.Off label drugs were likely the cause of the catheter occlusion.The patient had a successful surgery and had returned to normal therapy.No further complications were reported.
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