SMARTVIEW Adverse Event — Malfunction (MDR 1000165971-2020-00372)
SMARTVIEW Adverse Event — Malfunction (MDR 1000165971-2020-00372) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SMARTVIEW; Generic name: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS; Manufacturer: SORIN GROUP ITALIA S.R.L. - CRM FACILITY.
| Device | SMARTVIEW |
|---|---|
| Generic name | PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS |
| Manufacturer | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
| Report number | 1000165971-2020-00372 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | REPORTEDLY, THE REMOTE MONITOR AND THE WIREX PAIRING FAILED IN FEBRUARY 2020. A HEALTH CHECK FAILED ON THE 8 APRIL 2020, SO THE PATIENT WAS UNPAIRED FROM THE OLD DEVICE AND REPAIRED TO A NEW REMOTE MONITOR AND WIREX. THE OLD WIREX WAS STILL SHOWING TWO BARS OF RECEPTION AND IT WAS UNLIKELY LINKED TO THE FAILURE. |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →