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.
[110048117]
A (b)(6) y/o male pt s/p rvad developed significant gi bleeding which was hemodynamically unstable. During the workup for, anticoagulation was held. During this time he had a rise in ldh, increased watts/flows and worsening hemodynamic compromise. Pt was taken for urgent rvad exchange on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7567368 |
| MDR Report Key | 7567368 |
| Date Received | 2018-06-01 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-04-09 |
| Date Facility Aware | 2018-04-07 |
| Report Date | 2018-05-29 |
| Date Reported to Mfgr | 2018-04-10 |
| 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 | 12 DA |
| 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; 3. Required No Informationntervention | 2018-06-01 |