SYNCHROMED II Adverse Event — Injury (MDR 3004209178-2008-00740)
SYNCHROMED II Adverse Event — Injury (MDR 3004209178-2008-00740) 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: 3004209178-2008-00740.
| Device | SYNCHROMED II |
|---|---|
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Report number | 3004209178-2008-00740 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-15 |
| Report source | Health Professional |
| Narrative | THE HCP REPORTED THAT THE PT HAD OVERDOSE SYMPTOMS OF SOMNOLENCE, COGNITIVE CHANGES, AND RESPIRATORY PROBLEMS AFTER REPLACING HIS SYNCHROMED EL WITH A SYNCHROMED II PUMP. THE PT WAS IN THE INTENSITIVE CARE UNIT FOR SEVERAL WEEKS WITH THE OVERDOSE, IN THE SETTING OF PRE-EXISTING CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THE DRUG CONCENTRATION WAS NOT CHANGED AT IMPLANT; BOTH PUMPS WERE USED TO DELIVER |
| Source | openFDA MAUDE (device adverse events) |
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