FAST-PASS ACE Adverse Event — Injury (MDR 2017865-1997-00008)
FAST-PASS ACE Adverse Event — Injury (MDR 2017865-1997-00008) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FAST-PASS ACE; Generic name: PERMANENT PACEMAKER ELECTRODE; Manufacturer: PACESETTER INC..
| Device | FAST-PASS ACE |
|---|---|
| Generic name | PERMANENT PACEMAKER ELECTRODE |
| Manufacturer | PACESETTER INC. |
| Report number | 2017865-1997-00008 |
| Event type | Injury |
| Product problem | N |
| Date received | 1997-01-10 |
| Report source | User facility |
| Narrative | INFORMATION RECEIVED WITH RETURN OF THE EXPLANTED DEVICE DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES AN INFECTION.~~~~~~ |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →