MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
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 04/11/2022 |
Event Type
Injury
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Event Description
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Information was received from a healthcare professional (hcp) via a company representative (rep) regarding a patient receiving morphine (50 mg/ml at 6 mg/day) via an implanted pump.The indication for pump use was unknown.It was reported that the patient¿s catheter was not patent.The hcp was unable to aspirate cerebrospinal fluid (csf) during a dye study.The catheter was replaced on (b)(6) 2022 and discarded.There were no environmental, external, or patient factors that may have led or contributed to the issue.The issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury¿.The patient¿s weight and medical history were asked but unknown.
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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) 2022; product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 28-jul-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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