SYNCHROMED EL Adverse Event — Injury (MDR 6000030-2008-00794)
SYNCHROMED EL Adverse Event — Injury (MDR 6000030-2008-00794) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SYNCHROMED EL; Manufacturer: RICE CREEK MANUFACTURING; Report number: 6000030-2008-00794.
| Device | SYNCHROMED EL |
|---|---|
| Manufacturer | RICE CREEK MANUFACTURING |
| Report number | 6000030-2008-00794 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2008-02-19 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | IT WAS REPORTED THAT THE PT WAS ADMITTED TO THE HOSPITAL WITH INCREASED SPASTICITY. THROUGHOUT NOVEMBER & DECEMBER, THE PT'S DOSE SLOWLY INCREASED FROM 900 MCG/ML TO 1100 MCG/ML; ALL WITHOUT ANY PT IMPROVEMENT. THE DOSE WAS THEN DECREASED TO 1050 MCG/ML AND A FEW DAYS LATER, THE PT CAME IN WITH UNSPECIFIED SIGNS OF AN OVERDOSE. THE PUMP WAS REPROGRAMMED TO ITS MINIMUM RATE AND THE PT RECOVERED; HO |
| Source | openFDA MAUDE (device adverse events) |
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