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Model Number NEU_UNKNOWN_PUMP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id neu_unknown_cath, product type: catheter.(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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Information was received from a health care provider (hcp) via a manufacturer representative regarding an unknown patient with an im plantable drug infusion pump.No drug or medical history was provided.It was reported the patient had an unrelated spinal surgery that became suddenly infected, and the hcp thought the infection got to the catheter in the spine.The representative stated he had no details and the reason for his call was to request the pump off authorization form.The pump was alarming because the patient was due for refill, but they plan on explanting the system.
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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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