LEAD MODEL 302 Adverse Event — Malfunction (MDR 1644487-2020-00645)
LEAD MODEL 302 Adverse Event — Malfunction (MDR 1644487-2020-00645) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LEAD MODEL 302; Generic name: LEAD; Manufacturer: CYBERONICS - HOUSTON.
| Device | LEAD MODEL 302 |
|---|---|
| Generic name | LEAD |
| Manufacturer | CYBERONICS - HOUSTON |
| Report number | 1644487-2020-00645 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT DUE TO LOW BATTERY. ON THE DATE OF SURGERY, DURING THE PRE-OPERATIVE DIAGNOSTICS, IT WAS NOTED THAT THE PATIENT'S DEVICE SHOWED HIGH LEAD IMPEDANCE (9000 OHMS). THE SURGEON INDICATED HE WAS NOT PREPARED TO DO A FULL REVISION THAT DAY AND ONLY REPLACED THE GENERATOR. THE EXPLANTED GENERATOR WAS DISCARDED PER EXPLANTING HOSPITAL POLICY. A LEAD REVIS |
| Source | openFDA MAUDE (device adverse events) |
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