BIPOLAR ATRIAL "J" ENDOCARDIAL LEAD Adverse Event — Injury (MDR 2017865-1997-00026)
BIPOLAR ATRIAL "J" ENDOCARDIAL LEAD Adverse Event — Injury (MDR 2017865-1997-00026) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BIPOLAR ATRIAL "J" ENDOCARDIAL LEAD; Generic name: PERMANENT PACEMAKER ELECTRODE; Manufacturer: PACESETTER INC..
| Device | BIPOLAR ATRIAL "J" ENDOCARDIAL LEAD |
|---|---|
| Generic name | PERMANENT PACEMAKER ELECTRODE |
| Manufacturer | PACESETTER INC. |
| Report number | 2017865-1997-00026 |
| Event type | Injury |
| Product problem | N |
| Date received | 1997-01-10 |
| Report source | Health Professional, Company representation |
| Narrative | INFORMATION RECEIVED FROM THE FIELD INDICATES THE PATIENT APPEARED TO HAVE "SA NODE DISFUNCTION" AND WENT TO THE HOS- PITAL WITH A HEART RATE OF 30 BPM. LACK OF ATRIAL CAPTURE AND SENSING AND LOW ARIAL LEAD IMPEDANCE RESULTED IN RE-~~~~~ |
| Source | openFDA MAUDE (device adverse events) |
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