Model Number 8637-20 |
Device Problems
Failure to Interrogate (1332); Pumping Stopped (1503)
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Patient Problem
Muscular Rigidity (1968)
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Event Date 04/25/2017 |
Event Type
malfunction
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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 healthcare provide via a company representative regarding a patient receiving baclofen 3500mcg/ml, dose not reported, via an implantable pump.The indication for use was intractable spasticity and head/brain injury.The patient¿s medical history was noted as paralyzed.It was reported a pump stall occurred.It was unknown if any environmental, external or patient factors that may have led or contributed to the issue.They were unable to interrogate the pump.No actions were taken and the issue was not resolved at the time of the report.Surgical intervention did not occur and it was unknown if surgical intervention was planned.Additional information received reported that the patient went to the er (emergency room) and would manage spasticity using oral medication.No further patient complications have been reported as a result of this event.
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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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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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Additional information received reported that regarding the contributing factors of not being able to interrogate the pump the reporter stated they were not entirely sure, the patient was sent away before a company representative could attempt to read the pump.No further patient complications have been reported as a result of this event.
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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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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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