Model Number 8637-40 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Fall (1848); Itching Sensation (1943)
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Event Date 04/25/2016 |
Event Type
Injury
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 baclofen via an implanted pump.The indication for pump use was intractable spasticity and spinal cord injury/spinal cord disease.On (b)(6) 2017 it was reported that the patient fell before the pump was replaced.The hcp (healthcare professional) thought the fall could have occurred due to changes in the baclofen dosage prior to the pump replacement.The patient also had itchiness that started about 6 months prior to the pump replacement.The patient was on oral baclofen right before the pump was replaced.The hcp thought the itchiness was due to not getting consistent therapy with the pump and the patient was on oral baclofen.Diagnostic imaging was performed and no issues were determined.The patient was told that the pump was replaced because it was nearing eos (end of service) and it was ¿mechanically inconsistent¿.This had been determined a few months prior to the replacement.
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Manufacturer Narrative
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Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The pump was returned to the manufacturer via a healthcare provider.The pain pump was described as having reached end of life.
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Manufacturer Narrative
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Analysis of the pump found no significant anomalies; the pump logs indicated that end of service (eos) occurred due to time progression.Interrogation of the pump determined it was used to infuse lioresal [2000.0 mcg/ml] at 236.9 mcg/day.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.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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Manufacturer Narrative
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Corrected information: no eval explain code.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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