FAST-PASS Adverse Event — Injury (MDR 2017865-1997-00023)
FAST-PASS Adverse Event — Injury (MDR 2017865-1997-00023) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FAST-PASS; Generic name: PERMANENT PACEMAKER ELECTRODE; Manufacturer: PACESETTER INC..
| Device | FAST-PASS |
|---|---|
| Generic name | PERMANENT PACEMAKER ELECTRODE |
| Manufacturer | PACESETTER INC. |
| Report number | 2017865-1997-00023 |
| Event type | Injury |
| Product problem | Y |
| Date received | 1997-01-10 |
| Report source | Health Professional, User facility |
| Narrative | INFORMATION RECEIVED FROM THE FIELD DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES THAT "UPON INSPECTION, ATRIAL LEAD (1018T) HAD INSULATION RUPTURE."~~~~~ |
| Source | openFDA MAUDE (device adverse events) |
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