SYNCHROMED II Adverse Event — Injury (MDR 3004209178-2008-00726)
SYNCHROMED II Adverse Event — Injury (MDR 3004209178-2008-00726) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SYNCHROMED II; Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.; Report number: 3004209178-2008-00726.
| Device | SYNCHROMED II |
|---|---|
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Report number | 3004209178-2008-00726 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-15 |
| Report source | Consumer, Health Professional |
| Narrative | THE PATIENT INITIALLY REPORTED EXPERIENCING PRURITUS OVER HER ENTIRE BODY. FOLLOW UP WITH THE HCP INDICATED THE PRURITUS WAS CAUSED BY THE MORPHINE SULFATE INTRATHECAL TRIAL THAT HAD BEEN PREVIOUSLY PERFORMED. ADDITIONALLY, THE HCP REPORTED THE PATIENT DEVELOPED A HEMATOMA FOLLOWING IMPLANT OF THE INTRATHECAL DRUG DELIVERY PUMP. THE PUMP WAS PLACED IN 2007, DUE TO SEVERE BACK PAIN FOR WHICH THE PA |
| Source | openFDA MAUDE (device adverse events) |
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