MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-31 for HEARTMATE MEDTRONIC manufactured by Medtronic.
[173911547]
Pt admitted with one day hx of dark urine, feeling of humming in chest, and elevated ldh>1000. Concern for pump thrombus. No acute symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9539123 |
| MDR Report Key | 9539123 |
| Date Received | 2019-12-31 |
| Date of Report | 2019-12-11 |
| Date of Event | 2019-11-09 |
| Date Facility Aware | 2019-11-09 |
| Report Date | 2019-12-11 |
| Date Reported to FDA | 2019-12-11 |
| Date Added to Maude | 2020-01-02 |
| 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 | 3 |
| Brand Name | HEARTMATE MEDTRONIC |
| Generic Name | HEARTWARE |
| Product Code | OKR |
| Date Received | 2019-12-31 |
| Returned To Mfg | 2019-11-25 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | 500 OLD CONNECTICUT PATH RD FRAMINGHAM MA 01701 US 01701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-12-31 |