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N'VISION Adverse Event — Injury (MDR 2182207-2008-00796)

N'VISION Adverse Event — Injury (MDR 2182207-2008-00796) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: N'VISION; Manufacturer: MEDTRONIC NEUROMODULATION; Report number: 2182207-2008-00796.

DeviceN'VISION
ManufacturerMEDTRONIC NEUROMODULATION
Report number2182207-2008-00796
Event typeInjury
Product problemN
Date received2008-02-19
Report sourceForeign, Health Professional, Company representation
NarrativeTHE PT UNDERWENT A SUCCESSFUL TEST DOSE OF BACLOFEN (50 MCG). PER THE HCP, FOLLOWING THIS TEST DOSE, THEY ROUTINELY PERFORM A BOLUS AND SET THE CONTINUOUS INFUSION RATE AT 96 MCG/DAY; HOWEVER, THIS WAS TOO HIGH FOR THE PT WHO WAS A CHILD. THE PT WAS OVERDOSE AND STOPPED BREATHING. THE PT WAS TAKEN BACK TO THE "THEATRE"; THE DRUG WAS EXTRACTED FROM CATHETER AND THE PUMP; AND THE PT WAS SUCCESSFULLY
SourceopenFDA MAUDE (device adverse events)

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