MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Migration or Expulsion of Device (1395); Unexpected Therapeutic Results (1631); Patient-Device Incompatibility (2682); Unintended Movement (3026)
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Patient Problems
Diarrhea (1811); Fever (1858); Pain (1994); Increased Sensitivity (2065); Swelling (2091); Therapeutic Effects, Unexpected (2099); Chills (2191); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)
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Event Date 05/17/2018 |
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 receiving dilaudid, dose and concentration not reported via an implantable pump.The indication for use was non-malignant pain.On (b)(6) 2018 it was reported that the patient thought they were having a reaction to their pump replacement.The patient stated that this pump hasn't worked to help the pain like the last one, however the patient does get some relief with the pump.The patient was having severe pain and gets these episode like she was going through withdrawal.Per the patient the withdrawal symptoms would subside and then a month would go by and they would come back again.The patient experienced heightened sense of smell and taste, body chills, couldn't eat since saturday, fever, shakes, and loose stools.The patient stated that their healthcare provider refilled their pump on a friday and was changing the patient over from morphine to a different drug.The patient stated that she does have a lot of left over medication in the pump when she gets her refills but stated it¿s never been mentioned that it is a concern.The patient¿s healthcare provider has never done any tests on the pump either to look into the issue.Per the patient their pump was not alarming at that time.The patient had spoken to their healthcare provider about this and per the patient the healthcare provider stated he had never heard of this before.The patient was not hearing the pump alarming but one time when the patient bent over she did feel the pump flip.The patient tried to push it back in and now the patient feels their pump has moved down and there is swelling in their abdomen.The patient planned to follow up with their healthcare provider.No further complications were reported regarding the event.
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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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Search Alerts/Recalls
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