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Model Number 8637-20 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/03/2018 |
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 manufacturer representative (rep) regarding a patient who was receiving lioresal, 2250 mcg/ml concentration at 419.3 dose mcg/day via intrathecal drug delivery pump for intractable spasticity and cerebral palsy.It was reported that motor stall was seen at initial interrogation.Patient had an magnetic resonance imaging (mri) recently.Rep stated unknown if the mri was done due to a suspected problem with the manufacturer device or therapy.The rep was asked if she read the logs, had the motor stall recovery occurred and the rep answered no.It had not been less than 2 hours since patient exited the mri field.The rep stated that patient was in the hospital.The rep stated that she did not know why.No symptoms or problems with the pump or therapy were reported to her.The rep stated that she would come back later to interrogate the pump again.No further complications were reported.
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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 healthcare professional (hcp) via a manufacturer representative (rep).It was reported that the logs were read again to resolve the motor stall.The motor stall event had been resolved, the pump restarted.Patient's weight was unknown and no medical history was reported.No further complications were reported.
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Search Alerts/Recalls
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