CAPSURE SENSE LEAD MRI SURESCAN Adverse Event — Injury (MDR 2649622-2020-08393)
CAPSURE SENSE LEAD MRI SURESCAN Adverse Event — Injury (MDR 2649622-2020-08393) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CAPSURE SENSE LEAD MRI SURESCAN; Generic name: ELECTRODE, PACEMAKER, PERMANENT; Manufacturer: MPRI.
| Device | CAPSURE SENSE LEAD MRI SURESCAN |
|---|---|
| Generic name | ELECTRODE, PACEMAKER, PERMANENT |
| Manufacturer | MPRI |
| Report number | 2649622-2020-08393 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| 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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