SYNCHROMED II Adverse Event — Injury (MDR 3004209178-2020-07810)
SYNCHROMED II Adverse Event — Injury (MDR 3004209178-2020-07810) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SYNCHROMED II; Generic name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE; Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO..
| Device | SYNCHROMED II |
|---|---|
| Generic name | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Report number | 3004209178-2020-07810 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. THE PREVIOUSLY REPORTED EVALUATION CODES NO LONGER APPLY. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO |
| Source | openFDA MAUDE (device adverse events) |
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