TENDRIL STS Adverse Event — Malfunction (MDR 2017865-2020-05467)
TENDRIL STS Adverse Event — Malfunction (MDR 2017865-2020-05467) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TENDRIL STS; Generic name: PERMANENT PACEMAKER ELECTRODE; Manufacturer: ST. JUDE MEDICAL, INC.(CRM-SYLMAR).
| Device | TENDRIL STS |
|---|---|
| Generic name | PERMANENT PACEMAKER ELECTRODE |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Report number | 2017865-2020-05467 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | NEW INFORMATION RECEIVED NOTES THE LEAD ALSO EXHIBITED NOISE OVER-SENSING THAT LED TO INAPPROPRIATE AUTOMATIC MODE SWITCH. THE PATIENT WOULD CONTINUE TO BE MONITORED. |
| Source | openFDA MAUDE (device adverse events) |
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