Model Number 8637-20 |
Device Problems
Occlusion Within Device (1423); Volume Accuracy Problem (1675); Device Or Device Fragments Location Unknown (2590); Aspiration Issue (2883)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 8731, serial# (b)(4), implanted: (b)(6) 2004, product type catheter; product id: 8731, serial/lot #: (b)(4), ubd: (b)(6) 2006, udi#: (b)(4).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 provider (hcp) via a device manufacturer representative regarding a patient who was receiving an unknown drug via an implantable infusion pump for spinal pain, non-malignant pain, and other non-malignant pain.It was reported that there had been a reservoir volume discrepancy where they aspirated the same amount of drug at the pump refill that was placed in the pump at the previous refill.The patient was also experiencing withdrawal.The event date was asked but unknown.The hcp suspected a kink in the catheter.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 a healthcare professional (hcp) via a manufacturer representative.They went in to look at the catheter but were not able to aspirate.The hcp tied off the old catheter and left it in the patient and added a new one.
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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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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 a healthcare professional (hcp) via a manufacturer representative.It was reported that the hcp said the patient was doing fine after the surgery.No further complications were reported.
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Search Alerts/Recalls
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