MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Excess Flow or Over-Infusion (1311); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Application Program Problem (2880)
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Patient Problems
Pain (1994); Therapeutic Effects, Unexpected (2099)
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Event Date 11/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 8835, serial#: unknown, product type: programmer, patient.Other relevant device(s) are: product id: 8835, serial/lot #: unknown.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 patient and a healthcare professional (hcp) via a manufacturer's representative (rep).The patient was receiving an unknown concentration of bupivacaine at 1.999mg/day and an unknown concentration of morphine at 0.1199mg/day via an implantable infusion pump for non-malignant pain.It was reported that patient's hcp turned up the infusion rate.The non-critical alarm went off and the patient programmer (ptm) said "low reservoir." the critical alarm started going off because the pump was empty.The pump had been empty since (b)(6) 2019.The pump was flushed with saline, and then filled with morphine on (b)(6) 2019.After the refill the patient wasn't getting any relief from the pump.The volume of the reservoir was going to be checked.The patient reported that there is a ptm bolus request that is not accurate.The ptm will show that a bolus is delivered when they haven't been requested.The refill date on the ptm was also not accurate.No symptoms were reported.It was unknown if the issue was resolved, and the patient's status was noted as "alive-no injury." 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 an hcp on 2019-dec-24.It was reported that the instance of the patient being given a bolus even though one had not been requested was not confirmed to have occurred.The cause of the empty pump was administrative, and the pump was refilled.The lack of pain relief was resolved.
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Search Alerts/Recalls
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