HIGH PERFORMANCE ACE Adverse Event — Injury (MDR 2017865-1997-00019)
HIGH PERFORMANCE ACE Adverse Event — Injury (MDR 2017865-1997-00019) 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 | 2017865-1997-00019 |
| Event type | Injury |
| Product problem | Y |
| Date received | 1997-01-10 |
| Report source | Health Professional, Company representation |
| Narrative | INFORMATION RECEIVED FROM THE FIELD NOTES THAT THE PATIENT WAS PACEMAKER DEPENDENT AND HAD DIZZY SPELLS ALONG WITH NEAR SYNCOPAL EPISODES RESULTING IN A FALL AND A FRACTURED RIGHT WRIST. AN X-RAY SHOWED A GAP IN THE LEAD NEAR THE~~~~~ |
| Source | openFDA MAUDE (device adverse events) |
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