Model Number 8637-40 |
Device Problems
Device Operates Differently Than Expected (2913); Protective Measures Problem (3015)
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Patient Problems
Pain (1994); Therapeutic Response, Decreased (2271); 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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Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 company representative (rep) regarding a patient receiving an unknown intrathecal medication via an implanted pump for non-malignant pain and other chronic/intract pain (trunk/limbs).The pump was returned and it was noted on the returned product paperwork there was a complaint associated with the device; however further information was not provided.
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Manufacturer Narrative
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(b)(4).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 was reported by the company representative via a healthcare provider on 2017-mar-01.It was reported that the patient had experienced symptoms of withdrawal and increased pain.The pump had been read on (b)(6) 2016 which showed the pump had gone into safe state.The patient was admitted for pain control and the pump was programmed to minimum rate.It was noted that the pump had been replaced and there were no other known complaints; no further complications were reported.
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Manufacturer Narrative
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Analysis of the pump found battery high resistance.Interrogation of the device revealed it contained dilaudid.(b)(4) is no longer applicable.(b)(4) is being updated to (b)(4) for this event.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected (b)(4) because, although the device meets design specification, medtronic made enhancements to the design making this the closest code available with respect to this event.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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