MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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) 2015 explanted: (b)(6) 2021.
Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 27-jan-2017, 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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On 2022-apr-11, information was received from a manufacturer representative (rep), regarding a patient receiving morphine (40 mg/ml, 22 mg/day) via an implantable pump.
It was reported that during a replacement of an eri pump, they were unable to aspirate from the catheter access port (cap).
The patient had a history of volume discrepancies (3-5 ml).
It was stated that the hcp "found no links under x-ray with catheter tip at t11.
" the hcp did not want to flip the patient to probe due to health / heart condition so only the pump segment was replaced.
They would see if this resolved the issue before replacing the spinal segment.
It was unknown if the issue was resolved at the time of the report.
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Search Alerts/Recalls
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