MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/20/2021 |
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 consumer regarding a patient receiving baclofen via an implanted pump.The indication for pump use was intractable spasticity.The patient reported via an email on (b)(6) 2021 that he had a follow-up visit with his physicians on (b)(6) 2021 after his pump exchange and based on their feedback an error occurred with the pump service.He stated that it was discovered and observed during the visit on (b)(6) 2021 that the baclofen in his replacement pump was less than half (18.5 volume) and its capacity was 40.Per the patient it was to be filled to 100 percent at the replacement procedure.The data from the pump scan now suggested a refill in early to (b)(6) 2022, about 4 months from now, and not the 6-7 months that he was expecting.He stated that he was greatly concerned on a number of counts.He stated he was ¿greatly concerned and troubled physically, psychologically, mechanically, medically, and financially/cost-wise¿.Additional information was received from the patient via a phone call on (b)(6) 2021 at which time he reported that he was told the pump was filled to capacity but only had 18 ml, so they were concerned that the pump was leaking.Per the patient, he only had the pump filled two times per year.He stated that he was working with his hcp (healthcare provider) to get resolution.
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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 consumer regarding a patient receiving baclofen via an implanted pump.The indication for pump use was intractable spasticity.The patient reported via an email on (b)(6) 2021 that he had a follow-up visit with his physicians on (b)(6) 2021 after his pump exchange and based on their feedback an error occurred with the pump service.He stated that it was discovered and observed during the visit on (b)(6) 2021 that the baclofen in his replacement pump was less than half (18.5 volume) and its capacity was 40.Per the patient it was to be filled to 100 percent at the replacement procedure.The data from the pump scan now suggested a refill in early to (b)(6) 2022, about 4 months from now, and not the 6-7 months that he was expecting.He stated that he was greatly concerned on a number of counts.He stated he was ¿greatly concerned and troubled physically, psychologically, mechanically, medically, and financially/cost-wise¿.Additional information was received from the patient via a phone call on (b)(6) 2021 at which time he reported that he was told the pump was filled to capacity but only had 18 ml, so they were concerned that the pump was leaking.Per the patient, he only had the pump filled two times per year.He stated that he was working with his hcp (healthcare provider) to get resolution.
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Search Alerts/Recalls
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