TELIGEN Adverse Event — Injury (MDR 2124215-2020-07679)
TELIGEN Adverse Event — Injury (MDR 2124215-2020-07679) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TELIGEN; Generic name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT); Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | TELIGEN |
|---|---|
| Generic name | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2124215-2020-07679 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | IT WAS REPORTED THAT THERE WERE CONCERNS REGARDING PREMATURE BATTERY DEPLETION OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD). FURTHERMORE, THERE WERE DIFFERING LONGEVITY ESTIMATES GIVEN OVER THE LAST THREE MONTHS. DATA ANALYSIS WAS PERFORMED AND TECHNICAL SERVICES (TS) RECOMMENDED DEVICE REPLACEMENT BECAUSE OF THIS ANOMALY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE AND THIS |
| Source | openFDA MAUDE (device adverse events) |
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