SYNCHROMED EL Adverse Event — Malfunction (MDR 6000030-2008-00755)
SYNCHROMED EL Adverse Event — Malfunction (MDR 6000030-2008-00755) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SYNCHROMED EL; Manufacturer: RICE CREEK MFG; Report number: 6000030-2008-00755.
| Device | SYNCHROMED EL |
|---|---|
| Manufacturer | RICE CREEK MFG |
| Report number | 6000030-2008-00755 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional, Company representation |
| Narrative | IT WAS REPORTED THAT THE PT'S PUMP WAS FILLED WITH 18 MLS OF MORPHINE, BUT AT THE 2007 REFILL VISIT, 16 MLS WAS ASPIRATED FROM THE RESERVOIR. A ROLLER STUDY WAS PERFORMED AND IT SHOWED THE PUMP TO BE FINE. THE PUMP WAS THEN FILLED WITH 18 MLS OF DRUG. THE PT CAME BACK IN FOR A REFILL IN 2008 AND AGAIN 16 MLS WAS ASPIRATED FROM THE RESERVOIR. NO PT SYMPTOMS WERE REPORTED. ADD'L INFO HAS BEEN REQUES |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →