MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-06-18 for LEGEND II 8424 manufactured by Mdt Puerto Rico Operations Co, Med Rel.
| Report Number | 2647346-2019-00008 |
| MDR Report Key | 8706898 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-06-18 |
| Date of Report | 2019-06-19 |
| Date of Event | 2019-05-22 |
| Date Mfgr Received | 2019-06-18 |
| Date Added to Maude | 2019-06-18 |
| 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 | MDT PUERTO RICO OPERATIONS CO, MED REL |
| Manufacturer Street | ROAD 909, KM. 0.4., BARRIO MAR |
| Manufacturer City | HUMACAO PR 00792 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00792 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEGEND II |
| Generic Name | PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE |
| Product Code | LWO |
| Date Received | 2019-06-18 |
| Model Number | 8424 |
| Catalog Number | 8424 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT PUERTO RICO OPERATIONS CO, MED REL |
| Manufacturer Address | ROAD 909, KM. 0.4., BARRIO MAR HUMACAO PR 00792 US 00792 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 4024 | 1. Hospitalization; 2. Required No Informationntervention | 2019-06-18 |