MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-03 for SOLARA QUAD CRT-P MRI SURESCAN W4TR06 manufactured by Medtronic Europe Sarl.
[182482889]
Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed. Analysis of the device memory indicated that the atrial rate histogram data was missing/invalid. Analysis of the device memory indicated the egm (electrogram) was not available. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182482890]
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) exhibited no electrograms (egm) during wireless scheduled transmission. However, during manual transmission the egm was always present. Subsequently, analysis of device data resulted in an out of specification finding. The device remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614453-2020-00774 |
| MDR Report Key | 9782488 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-08-12 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC EUROPE SARL |
| Manufacturer Street | ROUTE DU MOLLIAU 31 CASE POSTALE |
| Manufacturer City | TOLOCHENAZ VAUD 1131 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 1131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLARA QUAD CRT-P MRI SURESCAN |
| Generic Name | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION |
| Product Code | NKE |
| Date Received | 2020-03-03 |
| Model Number | W4TR06 |
| Catalog Number | W4TR06 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC EUROPE SARL |
| Manufacturer Address | ROUTE DU MOLLIAU 31 CASE POSTALE TOLOCHENAZ VAUD 1131 CH 1131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-03 |