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Model Number 8637-20 |
Device Problems
Filling Problem (1233); Unstable (1667)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/14/2013 |
Event Type
malfunction
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Manufacturer Narrative
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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 consumer regarding a patient initially receiving prialt and morphine via an implanted pump.Since 2013, the pump had only been delivering morphine.The indication for pump use was failed back surgery syndrome and spinal pain.On (b)(6) 2018 it was reported that about 4 months after implant the patient lost around 30 pounds and since then the pump moved and flipped.The patient¿s physician was the only person that was able to fill the pump without making a lot pokes.No revision had yet been performed.The patient¿s physician was aware of the situation and she would be discussing replacement as the pump would need to be replaced in the near future due to the age of the pump.The patient had no symptoms related to the event.No further complications have been reported as a result of this event.
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Search Alerts/Recalls
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