MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Aspiration Issue (2883); Infusion or Flow Problem (2964)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of medical devices: product id 8709, serial# (b)(4), implanted: (b)(6) 2000, explanted: (b)(6) 2018, product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 06-apr-2002, udi#: (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 professional via a manufacturer's representative regarding a patient who was receiving 20 0mcg/ml compounded baclofen at 67mcg/day, 25mg/ml dilaudid at 7.5mg/day, and 275mcg/ml clonidine at 81mcg/day via an implantable infusion pump for chronic pain.It was reported that during a normal pump replacement due to battery life the doctor had difficulty asp irating the catheter.The catheter connector was replaced.It was reported the issue was resolved at the time of the report.The patient's status was noted as "alive-no injury." no further complications were anticipated/reported.
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Manufacturer Narrative
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Concomitant medical products: product id 8709, serial# (b)(4), implanted: (b)(6) 2000, explanted: (b)(6) 2018, product type catheter.The pump was returned, and analysis found corrosion and-or wear and-or lubrication and stall due to shaft-bearing.The catheter was returned and analysis found no significant anomalies.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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