Model Number 8637-20 |
Device Problems
Separation Failure (2547); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/29/2016 |
Event Type
malfunction
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Manufacturer Narrative
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References the main component of the device system; the other relevant components include: product id: 8780, serial# (b)(4), product type: catheter.Patient code applies to the catheter.Device code apply to the catheter.Eval code-conclusion code applies to the 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 professional via a company representative regarding a patient receiving morphine 1mg/ml for a total dose of 0.25mg/day via an implantable pump for non-malignant pain.It was reported on (b)(6) 2016 patient was having initial catheter and pump placement.It was noted they replaced the initial catheter.Intervention occurred as healthcare professional (hcp) introduced catheter into the intrathecal space, but had difficulty steering it.Hcp pulled it out along with the needle and found the guide wire extruded out of the catheter.It was noted issue was resolved at time of report and patient status was alive-no injury.It was noted there was no injury related to the issue described.It was noted no troubleshooting or diagnostics were performed.It was also stated there was no factors that may have led, contributed, or caused the issue.It was stated rep was present at the moment the hcp was introducing the catheter.Both the hcp and rep were notified of what happened.
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Manufacturer Narrative
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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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Additional information received on 2017-jan-11 from a company representative stated rep was present when this occurred and the device was sent to medtronic for analysis.
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Manufacturer Narrative
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The event was a product problem only.The intervention required box should not have been checked.The event was incorrectly reported as a serious injury and should be reported as a malfunction.
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Manufacturer Narrative
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The catheter was returned for analysis.Analysis of the catheter found damage to the guidewire that occurred during the implant procedure.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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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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