Model Number 8637-40 |
Device Problems
Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423); Material Integrity Problem (2978)
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Patient Problems
Dyspnea (1816); Overdose (1988); Therapeutic Response, Decreased (2271)
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Event Date 01/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of medical devices: product id 8596sc, serial# (b)(4), implanted: (b)(6) 2016, product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8596sc, serial/lot #: (b)(4), ubd: 10-feb-2018, 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 (b)(6) 2019, information was received from an healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving bupivacaine (unknown dose and concentration), baclofen (unknown dose and concentration) and dilaudid (unknown dose and concentration) via an implantable pump for spinal pain.On (b)(6) 2019, the patient presented at the emergency room (er) with withdrawal-type symptoms and was found to have a flipped pump.On (b)(6) 2018, they were checking the catheter and thought it was plugged.They ended up pushing forward and pushed the drug in the catheter through and a short time later, the patient was having trouble breathing (overdose symptoms) so 9-1-1 was called.The rep stated that "at some point they are planning to revise the catheter".
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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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Additional information was received that reported that the reporter had the old pump readings in the tablet and thought it was the new pumps information and that was the issue.The reporter was able to figure out the problem and program the patient effectively, everything was great.No further complications were reported or anticipated.
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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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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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Additional information was received and it was reported that the twisted part of the catheter was removed and replaced with a new catheter and a new anchored pump.The catheter failure was due to a flipped pump (multiple times) resulting in knotted catheter which caused poor infusion.Per the reporter follow up with the patient over the weekend and the patient was getting significant pain relief with no side effects.No further complications were reported or anticipated.
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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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Additional information was received on (b)(4) 2019 at which time it was reported that on (b)(6) 2019 the hcp (healthcare professional) was planning to do a catheter revision and possible pump replacement.Additional information was received the same day and it was reported that a dye study was done; they revised the twisted part of the existing catheter by cutting off that portion and replacing it with an 8596sc; and they replaced the pump as long as they had the patient opened up.Post-op the communicator was not communicating with the new pump.The reporter was planning to move away from emi (electromagnetic interference) and attempt communication again.No further complications were reported/anticipated.
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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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Additional information was received from a patient.It was reported that patient had "been in withdrawal for almost the last two months" (2019) and said the pump "had been flipping and i fell in march and ripped it from where it was and since then the pump would fall forward instead of being flat".The pump flipped but then a few weeks later, she went into the withdrawal and had to be oral medications.The healthcare professional (hcp) told her to call to report this information.The patient then reported that "the hcp said we might need to do something surgically".This pump had occurred in (b)(6) 2018 "when i was in withdrawal from that and was in the hospital for 5 days then in january i went to the hcp and the overdose happened in his office and they had to call ambulances and do narcan".With her current pump, she went to a refill on (b)(6) and "it gave back more drug than it said it should, so they didn't know if the catheter was kinked up or not and that was what happened with my last pump that was in january when i was in his office for the dye study with the overdose".No further complications were reported.
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Search Alerts/Recalls
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