FAST-PASS ACE Adverse Event — Injury (MDR 2017865-1997-00012)
FAST-PASS ACE Adverse Event — Injury (MDR 2017865-1997-00012) 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 | 2017865-1997-00012 |
| Event type | Injury |
| Product problem | N |
| Date received | 1997-01-10 |
| Report source | Health Professional |
| Narrative | INFORMATION RECEIVED FROM THE FIELD DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES CAPTURE AND SENSING ANOMALIES AND SUSPECTED 1ST RIB CLAVICLE CRUSH. THE VENTRICLAR LEAD SHOWED AN IMPEDANCE OF 200 OHMS AND THE~~~~~ |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →