MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-01 for MEDTRONIC manufactured by Heartware.
[110044199]
On (b)(6) 2018, pt admitted for one episode of dark brown urine. On admission found to have ldh 1344. Previously was normal on (b)(6) 2018 of ldh 270. He has some lv recovery on echo, and pt was taken for pump explant on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7567386 |
| MDR Report Key | 7567386 |
| Date Received | 2018-06-01 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-05-11 |
| Date Facility Aware | 2018-05-09 |
| Report Date | 2018-05-29 |
| Date Reported to Mfgr | 2018-05-11 |
| Date Added to Maude | 2018-06-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDTRONIC |
| Generic Name | HEARTWARE |
| Product Code | OKR |
| Date Received | 2018-06-01 |
| Device Availability | N |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEARTWARE |
| Manufacturer Address | 500 OLD CONNECTICUT PATH RD. FRAMINGHAM MA 01701 US 01701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2018-06-01 |