ORCHESTRA Adverse Event — Malfunction (MDR 1000165971-2020-00371)
ORCHESTRA Adverse Event — Malfunction (MDR 1000165971-2020-00371) 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 | 1000165971-2020-00371 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | REPORTEDLY, AN ERROR MESSAGE WAS DISPLAYED WHEN ATTEMPTING TO INTERROGATE AN ICD WITH THE SUBJECT PROGRAMMER. THE ISSUE COULD NOT BE SOLVED AFTER THE PROGRAMMER WAS REBOOTED SEVERAL TIMES. PROPER INTERROGATION OF A PACEMAKER COULD BE PERFORMED WITH THE PROGRAMMER. |
| Source | openFDA MAUDE (device adverse events) |
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