ORCHESTRA Adverse Event — Malfunction (MDR 1000165971-2020-00376)
ORCHESTRA Adverse Event — Malfunction (MDR 1000165971-2020-00376) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ORCHESTRA; Generic name: PROGRAMMER, PACEMAKER; Manufacturer: SORIN GROUP ITALIA S.R.L. - CRM FACILITY.
| Device | ORCHESTRA |
|---|---|
| Generic name | PROGRAMMER, PACEMAKER |
| Manufacturer | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
| Report number | 1000165971-2020-00376 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | REPORTEDLY, IT WAS OBSERVED THAT THE SERIAL NUMBER DISPLAYED ON THE PROGRAMMER SCREEN WAS DIFFERENT FROM THE ONE INDICATED ON THE LABEL ON THE PROGRAMMER SHELL. PRELIMINARY ANALYSIS REVEALED THAT THE REPORTED ISSUE MOST PROBABLY RESULTED FROM A HUMAN ERROR DURING REFURBISHMENT OF THE SUBJECT PROGRAMMER. |
| Source | openFDA MAUDE (device adverse events) |
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