MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Positioning Problem (3009)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 01/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 10-feb-2018, 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 receiving morphine (500 mcg/ml at 75 mcg/day) via an implanted pump.It was reported that the patient¿s catheter was replaced to place the catheter tip at a new location due to reported lack of effect with initial catheter.There was no known environmental, external, or patient factors that may have led or contributed to the issue.The diagnostics/troubleshooting performed was noted to be that a new pump trial was performed, and the patient reported improved pain relief.During the procedure, the catheter was removed, and a new catheter was implanted.The pump was also replaced at the time of surgery.The issue was noted to be resolved and it was indicated that the hcp had no further information to provide regarding the event.
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