MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Electromagnetic Interference (1194); Data Problem (3196)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: a810, product type: software.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) on (b)(6) 2019 regarding a patient receiving lioresal (2000mcg/ml at a flex dose of 964.9mcg/day) via an implanted infusion pump.The indications for use included intractable spasticity and cerebral palsy.It was reported that there was a pump refill on the date of report, and when the pump was first telemetried code 112 was confirmed.It was indicated that a memory error had occurred and that all information had been "wiped out." per the event logs, the last pump update occurred on (b)(6) 2019 and the logs were normal with no memory error confirmed via the event logs.The hcp had the patient move away from sources of electromagnetic interference (emi), and would call back if she encountered further issues after reprogramming the pump with all the flex steps and updating the reservoir volume.No symptoms were reported and no further complications were reported or anticipated.
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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 a healthcare professional (hcp).During the programming session, they determined that emi was the cause of the error.Once the patient was moved away from the emi, the error cleared and they were able to program the pump successfully.No further issues were reported or anticipated.
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Search Alerts/Recalls
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