Model Number 8637-40 |
Device Problems
Occlusion Within Device (1423); Obstruction of Flow (2423); Aspiration Issue (2883); Infusion or Flow Problem (2964)
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Patient Problem
Pain (1994)
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Event Date 06/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.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 via a device manufacturer representative regarding a patient who was receiving an unknown drug via an implantable infusion pump for non-malignant pain.It was reported that the patient complained of increased pain.The healthcare provider (hcp) was unable to aspirate the catheter at a dye study on (b)(6) 2018.A catheter revision was done.The catheter appeared to be occluded at the pocket.The pump segment was replaced.Then, the catheter was aspirated normally.The issue was resolved at the time of the report.The patient's status at the time of the report was 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 the healthcare professional via manufacturer representative.It was reported that the catheter portion would be returned, and the pump remained implanted.No further complications were reported.
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Manufacturer Narrative
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Continuation: product id 8780 lot# serial# (b)(4) implanted: 2017 (b)(6) explanted: product type catheter: analysis of the catheter found damage at the sc assembly.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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