ISOFLEX OPTIM LEAD Adverse Event — Injury (MDR 2017865-2020-05429)
ISOFLEX OPTIM LEAD Adverse Event — Injury (MDR 2017865-2020-05429) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ISOFLEX OPTIM LEAD; Generic name: PERMANENT PACEMAKER ELECTRODE; Manufacturer: ST. JUDE MEDICAL, INC.(CRM-SYLMAR).
| Device | ISOFLEX OPTIM LEAD |
|---|---|
| Generic name | PERMANENT PACEMAKER ELECTRODE |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Report number | 2017865-2020-05429 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | Foreign, Health Professional, User facility, Company representation |
| Narrative | THIS PRODUCT IS REGISTERED AS A COMBINATION PRODUCT. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. |
| Source | openFDA MAUDE (device adverse events) |
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