SPRINT QUATTRO SECURE S MRI SURESCAN Adverse Event — Injury (MDR 3008973940-2020-00989)
SPRINT QUATTRO SECURE S MRI SURESCAN Adverse Event — Injury (MDR 3008973940-2020-00989) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SPRINT QUATTRO SECURE S MRI SURESCAN; Generic name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT); Manufacturer: MEDTRONIC SINGAPORE OPERATI
| Device | SPRINT QUATTRO SECURE S MRI SURESCAN |
|---|---|
| Generic name | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) |
| Manufacturer | MEDTRONIC SINGAPORE OPERATIONS |
| Report number | 3008973940-2020-00989 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | 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 FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVAN |
| Source | openFDA MAUDE (device adverse events) |
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