Model Number 8637-20 |
Device Problems
Aspiration Issue (2883); Difficult to Advance (2920); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/02/2017 |
Event Type
Injury
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Manufacturer Narrative
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Other applicable components are: product id 8731sc lot# serial# (b)(4) implanted: (b)(6) 2012 product type catheter.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 healthcare provider via a company representative regarding a patient receiving an unknown drug via an implantable pump.The indication for use was non malignant pain and spinal stenosis.A possible catheter issue was reported.The environmental, external or patient factors that may have led or contributed to the issue it was reported that the patient had an un related chest x-ray and saw image, possible catheter disconnect.Diagnostics and or troubleshooting performed was a dye study was attempted, date unknown, but they were unable to aspirate.The actions and or interventions taken to resolve the issue was the patient would be scheduled for a catheter revision.The issue was not resolved at the time of the report and the patient status was noted as alive, no injury.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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The main component of the system and other applicable components are: product id: neu_unknown_cath, serial# unknown, 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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Additional information was received and it was reported that the patient was taken to surgery on (b)(6) 2017 to revise the damaged catheter that was seen on x-ray.The revision was aborted secondary to being unable to advance the catheter.The spinal segment of the catheter was removed and the pump remained implanted.Per the reporter, the patient may be referred to a neurosurgeon.The issue was noted to be resolved at the time of the report and the patient status was reported as ¿alive ¿ no injury¿.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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(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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Additional information received reported that the cause for the inability to advance the catheter was unknown.The catheter was advanced about 1.5 vertebral bodies and couldn¿t advance further.It was unable to advance based on anatomical issues and no catheter issue was suspected.No further patient 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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Search Alerts/Recalls
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