Model Number 8637-40 |
Device Problems
Premature End-of-Life Indicator (1480); Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: neu_unknown_prog, serial# unknown, product type programmer, physician.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 device manufacturer representative (rep) regarding a patient who was receiving 500 mcg/ml baclofen at an unknown dose via an implantable pump for intractable spasticity and familial spastic paraparesis.It was reported that a critical alarm was occurring.The pump was interrogated on (b)(6) 2017 and it was noted that eri was reached on (b)(6) 2016.It was explained that the pump had reached end of service (eos) and needed to be replaced.No symptoms were reported and the event date was unknown.
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Event Description
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Additional information was received from a device manufacturer representative (rep) and healthcare provider (hcp).The patient was referred to have their pump replaced, no symptoms of withdrawal were reported, and the pump was noted to be 7 years old.The healthcare provider (hcp) had notified the rep of the event and used their own programmer.
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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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