MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 01-oct-2021, 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 (hcp) via a company representative regarding a patient going to be receiving dilaudid (5 mg/ml at 500 mcg/day) via an implanted pump.During the initial device implant procedure on (b)(6) 2020, the physician could not get the catheter advanced past the needle tip.He pulled the needle out and the catheter did advance.He then attempted catheter advancement using the same needle, but the catheter would not advance.A new catheter was opened and that one also did not advance.He then tried a new needle and the catheter advanced easily.The pump was then implanted without issue.There were no environment factors that may have caused or contributed to the issue.The patient had no symptoms.The event occurred intra-operatively.The issue was resolved, and it was indicated that the hcp had no further information to provide regarding the event.The patient status was reported as ¿alive ¿ no injury¿.No further complications were reported/anticipated.
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Manufacturer Narrative
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Product id: 8780, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: catheter.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product id: 8780, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: catheter.Visual inspection identified damage/foreign material in the introducer needle.If information is provided in the future, a supplemental report will be issued.
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