SYNCHROMED EL Adverse Event — Injury (MDR 6000030-2008-00688)
SYNCHROMED EL Adverse Event — Injury (MDR 6000030-2008-00688) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SYNCHROMED EL; Manufacturer: RICE CREEK MANUFACTURING; Report number: 6000030-2008-00688.
| Device | SYNCHROMED EL |
|---|---|
| Manufacturer | RICE CREEK MANUFACTURING |
| Report number | 6000030-2008-00688 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional, Company representation |
| Narrative | IT WAS REPORTED THAT A MOTOR STALL WAS CONFIRMED BY ROTOR STUDY IN 2008. THE PUMP CONTAINED MORPHINE AND COMPOUNDED BACLOFEN. THE HCP REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS INCLUDING THE FOLLOWING: HYPERTONIA, NAUSEA, VOMITING, INCREASED PAIN, AND SPASTICITY. THE PUMP WAS EXPLANTED AND REPLACED; THE PATIENT RECOVERED WITHOUT SEQUELA. THE DEVICE WOULD BE RETURNED FOR ANALYSIS. |
| Source | openFDA MAUDE (device adverse events) |
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