MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for MICRA MC1VR01 manufactured by Medtronic Ireland.
[184431224]
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 a partial power on reset occurred. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184431225]
It was reported that a power on reset (por) occurred on the leadless implantable pulse generator (ipg). The ipg 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 | 9612164-2020-01283 |
| MDR Report Key | 9864485 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2015-11-10 |
| Date Added to Maude | 2020-03-23 |
| 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 IRELAND |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRA |
| Generic Name | LEADLESS PACEMAKER |
| Product Code | PNJ |
| Date Received | 2020-03-23 |
| Model Number | MC1VR01 |
| Catalog Number | MC1VR01 |
| Device Expiration Date | 2017-04-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC IRELAND |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-23 |