ENDOTAK RELIANCE G Adverse Event — Malfunction (MDR 2124215-2020-09186)
ENDOTAK RELIANCE G Adverse Event — Malfunction (MDR 2124215-2020-09186) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENDOTAK RELIANCE G; Generic name: IMPLANTABLE LEAD; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | ENDOTAK RELIANCE G |
|---|---|
| Generic name | IMPLANTABLE LEAD |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2124215-2020-09186 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING SHOCK IMPEDANCES, SUBSEQUENTLY REACHING A HIGH OUT OF RANGE MEASUREMENT OF 131 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INDICATED THAT TYPICALLY A GRADUAL RISE IN SHOCK IMPEDANCES IS DUE TO CALCIFICATION OR SCAR TISSUE FORMATION AND EXPLAINED TO THE BOSTON SCIENTIFIC REPRESENTATIVE ABOUT THE CONCERN WHEN THE DELIVERED SH |
| Source | openFDA MAUDE (device adverse events) |
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