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Model Number 8637-40 |
Device Problems
Occlusion Within Device (1423); Obstruction of Flow (2423); Battery Problem (2885); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)
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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: 8709, serial#: (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2018 product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 15-aug-2013, udi#: (b)(4).Interrogation of the device indicated that 1,000 mcg/ml baclofen at 158.9 mcg/day was being delivered.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 professional (hcp) regarding the patient¿s implantable drug infusion device.The drug being delivered was gablofen.The reason for use was not reported.It was reported that there was battery depletion.The catheter was unable to withdraw/aspirate (only partial catheter), there was an occlusion.There was no dye study performed.The patient was not in a clinical study, the device was used with/in the patient for treatment.There was no patient death.The pump and catheter were returned to the manufacturer.There were no symptoms reported.There were no further complications reported/anticipated.
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Manufacturer Narrative
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Analysis of the pump found that there was over infusion with an undetermined root cause.Analysis of the catheter found that the catheter body was broken.(b)(4).If information is provided in the future, a supplemental report will be issued.
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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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