SMARTTOUCH Adverse Event — Malfunction (MDR 1000165971-2020-00377)
SMARTTOUCH Adverse Event — Malfunction (MDR 1000165971-2020-00377) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SMARTTOUCH; Generic name: PROGRAMMER, PACEMAKER; Manufacturer: MANUFACTURED FOR MICROPORT CRM S.R.L..
| Device | SMARTTOUCH |
|---|---|
| Generic name | PROGRAMMER, PACEMAKER |
| Manufacturer | MANUFACTURED FOR MICROPORT CRM S.R.L. |
| Report number | 1000165971-2020-00377 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | REPORTEDLY, IT WAS NOT POSSIBLE TO INTERROGATE ICDS WITH THE SUBJECT PROGRAMMING HEAD AND TWO SMARTTOUCH TABLETS. PRELIMINARY ANALYSIS REVEALED THAT THE REPORTED BEHAVIOR COULD BE DUE TO BAD POSITIONING OF THE HEAD OVER THE IMPLANT, AN ISSUE WITH THE SUBJECT PROGRAMMING HEAD AND/OR AN ISSUE WITH THE ASSOCIATED DONGLE. |
| Source | openFDA MAUDE (device adverse events) |
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