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.
| Device | N'VISION |
|---|---|
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Report number | 2182207-2008-00796 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-19 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | THE 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 |
| Source | openFDA MAUDE (device adverse events) |
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