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Model Number 8637-40 |
Device Problem
Failure To Service (1563)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/25/2018 |
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 and a manufacturer representative on (b)(6) 2018 regarding a patient receiving unknown medi cation (dose and concentration unknown) via an implanted infusion pump.The indications for use included non-malignant pain and failed back surgery syndrome.It was noted that prior to pump implant, about six months after the patient got back surgery in late 2002/early 2003, the patient was on fentanyl patches and ran out of patches.The patient went through complete withdrawal for two days and the healthcare provider (hcp) had to (b)(6) fentanyl overnight.It was reported that the patient was supposed to be filled on monday (relative to the date of report), but was not filled because the doctor was found dead.The patient called around and couldn't find a doctor to fill the pump.Per a manufacturer representative, a new hcp agreed to take the patient, and the patient was calling the office on (b)(6) 2018.No patient symptoms were reported and 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 from the manufacturer representative on (b)(6) 2018.It was indicated the patient had been referred to a new managing physician.However, it was unknown if the missed refill issue had been resolved at the time of the report.The patient's weight was unknown.
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Search Alerts/Recalls
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