Model Number 8637-20 |
Device Problems
Pumping Stopped (1503); Mechanical Jam (2983)
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Patient Problem
Muscle Spasm(s) (1966)
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Event Date 06/28/2017 |
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 healthcare provider regarding a consumer receiving lioresal [2000 mcg/ml] at a rate of 197.1 mcg/day via intrathecal drug delivery pump for intractable spasticity.It was reported that there was a motor stall seen at initial interrogation.The patient recently had an mri and did not have the pump interrogated on the day of the mri.The motor stall occurred on the same day of the mri and when the patient was seen on (b)(6) 2017, her next scheduled refill date, and the pump was still stalled.The patient reports that the pump is still alarming and she doesn't feel any better, including sudden increased spasms.
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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 received reported that the patient came in to see the healthcare provider on (b)(6) 2017.Per the patient they had an mri in (b)(6).When the patient saw the healthcare provider in july the patient¿s pump was in a motor stall, exceeding pump tubing time.The environmental, external or patient factors that may have led or contributed to the issue was the motor stall did not recover after an mri.The diagnostics and trouble shooting were reported as a rotor study was performed and the healthcare provider was able to restart the pump with the 8840 physician programmer.The actions and interventions taken to resolve the issue were the patient was referred for a pump replacement.The pump was explanted on (b)(6) 2017.The issue was resolved at the time of the report and the patient¿s status was noted as alive, no injury.No further patient complications were reported or anticipated.
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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.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 and catheter were returned to the manufacturer.
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Manufacturer Narrative
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The pump was returned, and analysis found no evidence of anomalies.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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