Information was received by a consumer (con) regarding a patient who was receiving dilaudid (hydromorphone) (unknown concentration or dose) via implantable infusion pump.It was reported that the patient would be scheduled for refills 4 weeks prior to the pump's low reservoir alarm date, but the pump would be empty at the time of refill.The patient stated that when they would have refills, they would "pass out".The patient stated that when they had their initial fill "on the 29th" (believed to be (b)(6) 2017), the patient passed out on their floor, "and 4 days later they found me".The patient stated that "the alarm never went off".The patient stated they had a "huge overdose" and ended up in intensive care.The patient stated that their physician believed the patient had 20 times their dosage and now the patient "can't feel my toes and i suffer with my memory a lot.I have a lot of anxiety now and i used to be outgoing".It was noted that the patient's pump was removed on (b)(6) 2020 because of this.The patient is requesting the status of their pump analysis as their healthcare provider has not heard anything yet.Of note, the product lookup indicated that the device has not been received by medtronic.Additional information was received by the hcp who reported that the patient did not start to complain about adverse reactions related to their pump until (b)(6) 2021.It was reported that after the patient had a pump refill on (b)(6) 2020 the patient became altered with impaired cognition.The patient was found unresponsive by the police and was taken to the icu for 5-7 days.It was noted that the patient had been disoriented for 14 days.The patient was found to have a high volume of dilaudid in the patient's urine; however, the pump was empty and the patient's toxicity level was negative for dilaudid.It was reported that a portion of the dilaudid was not placed in the pump but in the pump pocket, although not said with certainty.The plan had been to taper the patient off the medication and then remove the pump.It was noted that the patient's pump removal was performed at a different facility and the hcp was unsure of the status of the pump.The hcp was unable to provide contact information on the facility mentioned.Additionally, the hcp stated being uncertain that the patient's symptoms ("can't feel my toes and i suffer with my memory a lot.I have a lot of anxiety now and i used to be outgoing") was related to the pump.The hcp stated that the patient was put on many different medications while in the icu as well as for other diagnoses unrelated to the pump (medication including norco and gabapentin) that may have contributed to their reported symptoms.The hcp reported that the patient was last seen on (b)(6) 2021 and did not report any side effects.Of note, the hcp denied patient history with refill issues related to patient's pump being empty at scheduled low reservoir date refills or patient reporting "passing out".The hcp stated that at each refill starting from (b)(6) 2017 the patient reported no changes or adverse reactions; however, the patient had a fever on (b)(6) 2021 unrelated to the pump so they had to reschedule their refill and on (b)(6) 2021 the patient had requested to have the device removed that was unrelated to device issues.The hcp reported that the issue had been resolved.Of note, the patient's medical history included chronic abdominal pain and surgery related to hypoplastic right kidney.
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