SYNCHROMED II Adverse Event — Injury (MDR 2182207-2008-00722)
SYNCHROMED II Adverse Event — Injury (MDR 2182207-2008-00722) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SYNCHROMED II; Manufacturer: MEDTRONIC NEUROMODULATION; Report number: 2182207-2008-00722.
| Device | SYNCHROMED II |
|---|---|
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Report number | 2182207-2008-00722 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-15 |
| Report source | Health Professional |
| Narrative | IT WAS REPORTED THAT THE PT'S NEW PUMP WAS PROGRAMMED WITH THE SAME CONCENTRATION AND DOSE AS THE OLD PUMP; HOWEVER, POST PUMP REPLACEMENT, THE PT EXPERIENCED COGNITIVE SYMPTOMS, SOMNOLENCE, WEAKNESS, HALLUCINATIONS, DELUSIONS, AND DISORIENTATION. ALL WERE ATTRIBUTED TO THE PT RECEIVING TOO MUCH MEDICATION FOLLOWING THE REPLACEMENT. THE PUMP DOSE OF DILAUDID WAS TITRATED DOWN SEVERAL TIMES FROM 4. |
| Source | openFDA MAUDE (device adverse events) |
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