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Model Number 8637-40 |
Device Problem
Pumping Stopped (1503)
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Patient Problems
Rash (2033); Therapeutic Response, Decreased (2271); Sweating (2444)
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Event Date 11/11/2018 |
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 healthcare provider (hcp) via a device manufacturer representative regarding a patient receiving clonidine (200 mcg/ml at 109.91 mcg/day), baclofen (400 mcg/ml at 219.91 mcg/day) and dilaudid (20 mg/ml at 10.991 mg/day) via an implantable infusion pump.The indication for use was non-malignant pain and failed back surgery syndrome.It was reported that a motor stall/stopped pump period may exceed tube set was seen during interrogation of the pump.It was noted that the patient did not recently have an magnetic resonance imaging performed.The caller stated that the patient was having withdrawal symptoms and reported profuse sweating and the development of a rash across their chest.It was noted that the healthcare provider (hcp) was determining if the rash was drug related.No further complications have been reported as a result of this 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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