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Model Number 8637-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Unspecified Infection (1930); Pain (1994); Rash (2033); Swelling (2091)
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Event Date 04/30/2017 |
Event Type
Injury
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Manufacturer Narrative
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References the main component of the device system; the other relevant components include: product id: 8780, serial# (b)(4), implanted: (b)(6) 2013, product type: catheter.(b)(4).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 manufacturer representative regarding a patient receiving unknown baclofen with an unknown dose and concentration via an implantable pump for intractable spasticity and stiff man's syndrome.It was reported that the patient feels "throbbing underneath the pump" and has a red rash around the pump that tracks around to the patient's back where the catheter is inserted.It was noted there was also swelling and it was painful for the patient.The healthcare professional (hcp) did an ultrasound and there was no fluid.It was noted that the patient's situation was being addressed by the hcp.It was noted that hcp inquired if this was something manufacturer has heard of before and it was reviewed that the issue was medical in nature and should be addressed buy the hcp.Event date was noted as (b)(6) 2017.Additional information received on (b)(6) 2017 from a manufacturer representative reported healthcare professional (hcp) reported this information to the rep the day that the rep reported it.At that time, the rep was told it had happened before.The hcp does not know what was causing the issue.Additional information received from healthcare professional via drug partner on (b)(6) 2017 reported medical history included implantation of a synchromed ii pump and an ascenda catheter on (b)(6) 2013.It was stated that the patient felt the throbbing underneath the pump and experienced the rash around the pump after a refill.It was noted that the healthcare professional (hcp) gave the patient an unspecified antibiotic and "it went away." on (b)(6) 2017, the patient experienced a reoccurrence of the same symptoms.It was noted that the cause of the issue was undetermined.On (b)(6) 2017, it was learned that the patient¿s medical history included implantation of an unknown intrathecal pump in (b)(6) 2012.Concomitant products included xarelto (rivaroxaban).On an unspecified date in (b)(6) 2012, the patient started treatment with intrathecal baclofen therapy.After the patient¿s last refill on (b)(6) 2017, the patient developed a rash around the pump and on their abdomen.This rash was reported to the hcp on (b)(6) 2017.For treatment the rash was observed.On unspecified dates in 2017, the rash improved and then resolved.Treatment with baclofen was not discontinued in response to the reported events.As of (b)(6) 2017, the patient¿s treatment included baclofen 5000 mg/ml at 1553.3mg/day.No further complications were reported/anticipated.
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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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Manufacturer Narrative
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Changed from product problem to product problem and adverse event.
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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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Search Alerts/Recalls
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