PULSE GEN MODEL 103 Adverse Event — Injury (MDR 1644487-2020-00633)
PULSE GEN MODEL 103 Adverse Event — Injury (MDR 1644487-2020-00633) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PULSE GEN MODEL 103; Generic name: GENERATOR; Manufacturer: LIVANOVA USA, INC..
| Device | PULSE GEN MODEL 103 |
|---|---|
| Generic name | GENERATOR |
| Manufacturer | LIVANOVA USA, INC. |
| Report number | 1644487-2020-00633 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT WAS REPLACED DUE TO INTENSIFIED FOLLOW-UP INDICATOR = YES. EXPLANTED PRODUCT HAS NOT BEEN RECEIVED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. |
| Source | openFDA MAUDE (device adverse events) |
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