MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for MICRA MC1VR01US manufactured by Medtronic Ireland.
[189091819]
Section d information references the main component of the system. Other relevant device(s) are: micra, model #: mc1vr01-delsys / expiration date: 28-may-2021 / serial#: (b)(4), udi #: (b)(4), device available for evaluation: yes, return date: 10mar2020, device evaluated by manuf: no, device evaluation anticipated, but not yet begun dev rtn to mfr? Yes h4: mfg date: 21-jan-2020 h5: yes, (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[189091820]
It was reported that during the implant procedure, a tough time was encountered by the physician pulling the leadless implantable pulse generator (ipg) delivery system (ds) tether after it was cut. It was further reported that the leadless ipg became dislodged. The leadless ipg system was removed and replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01399 |
| MDR Report Key | 9897406 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2020-01-21 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Returned To Mfg | 2020-03-10 |
| Model Number | MC1VR01US |
| Catalog Number | MC1VR01US |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 | 2020-03-30 |