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N'VISION Adverse Event — Injury (MDR 2182207-2008-00728)

N'VISION Adverse Event — Injury (MDR 2182207-2008-00728) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: N'VISION; Manufacturer: MEDTRONIC NEUROMODULATION; Report number: 2182207-2008-00728.

DeviceN'VISION
ManufacturerMEDTRONIC NEUROMODULATION
Report number2182207-2008-00728
Event typeInjury
Product problemN
Date received2008-02-15
Report sourceHealth Professional
NarrativeTHE HCP REPORTED THE PATIENT WAS EXPERIENCING "NEUROLOGICAL ISSUES" FOLLOWING A PROGRAMMING ERROR THE DAY BEFORE. A BRIDGE BOLUS WAS BEING PROGRAMMED DUE TO A CHANGE IN MEDICATION CONCENTRATION. THE DRUG USED IN THE PUMP WAS FENTANYL 3800 MCG/ML AT A DOSE OF 2000 MCG/DAY, AND THE NEW DRUG WAS SUFENTANIL 400 MCG/DL AT A DOSE OF 200 MCG/DAY. THE VOLUME BRIDGED WAS 0.485 ML. THE ERROR WAS MADE WHEN T
SourceopenFDA MAUDE (device adverse events)

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