MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-03-26 for MICRA MC1VR01 manufactured by Medtronic Ireland.
[185078712]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185078713]
It was reported that the patient experienced lost of consciousness and collapsed. Complete heart block was observed on the electrocardiogram (ecg). Percutaneous pacing was not successful and the adrenaline was administered and was followed by induced hypothermia. It was reported that patient underwent an extended aortic valve/root reconstruction and replacement procedure. Leadless implantable pulse generator (ipg) was explanted and replaced with conventional ipg since the endocarditis with sepsis was suspected. Followed by an extensive and prolonged hospitalization, this patient developed respiratory heart failure based on sputum impaction. It was reported that the patient experienced cardiac arrest and consequently died. The patient was a participant in the post approval clinical surveillance product surveillance registry.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01365 |
| MDR Report Key | 9884485 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-10-29 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2019-01-23 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| Model Number | MC1VR01 |
| Catalog Number | MC1VR01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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. Death | 2020-03-26 |