MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 8709sc; serial#: (b)(4); implanted: (b)(6) 2009; explanted: (b)(6) 2022; product type catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 02-oct-2011, 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 provider (hcp) via a company representative regarding a patient receiving baclofen (1500 mcg/ml at 350 mcg/day) via an implanted pump.It was reported that during the scheduled pump replacement procedure when the hcp attempted to aspirate through the side port, the catheter would not aspirate.There were no environmental, external, or patient factors that may have led or contributed to the issue.The pump segment of the catheter was replaced using a revision kit and then the hcp was able to aspirate through the side port.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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