HIGH PERFORMANCE ACE Adverse Event — Malfunction (MDR 2017865-1997-00020)
HIGH PERFORMANCE ACE Adverse Event — Malfunction (MDR 2017865-1997-00020) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HIGH PERFORMANCE ACE; Generic name: PERMANENT PACEMAKER ELECTRODE; Manufacturer: PACESETTER INC..
| Device | HIGH PERFORMANCE ACE |
|---|---|
| Generic name | PERMANENT PACEMAKER ELECTRODE |
| Manufacturer | PACESETTER INC. |
| Report number | 2017865-1997-00020 |
| Event type | Malfunction |
| Product problem | N |
| Date received | 1997-01-10 |
| Report source | Foreign, Health Professional, User facility |
| Narrative | INFORMAITON RECEIVED FROM THE FIELD DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES A SENSING ANOMALY.~~~~~~ |
| Source | openFDA MAUDE (device adverse events) |
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