MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-27 for HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE 102953 manufactured by Thoratec Corporation.
[183374338]
No further information was provided. A supplemental report will be submitted when the manufacturer? S investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[183374339]
The patient was implanted with heartmate ii lvad on (b)(6) 2011. Due to a declining right ventricle function, the patient received an rvad implant on (b)(6) 2011 for right heart support. On (b)(6) 2011, the rvad was explanted due to recovery. No further information was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01058 |
| MDR Report Key | 9766032 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2011-10-15 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-02-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BOB FRYC |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 7818528204 |
| Manufacturer G1 | THORATEC CORPORATION |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 95488 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95488 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE |
| Generic Name | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
| Product Code | KFM |
| Date Received | 2020-02-27 |
| Model Number | 102953 |
| Catalog Number | 102953 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORPORATION |
| Manufacturer Address | 6035 STONERIDGE DRIVE PLEASANTON CA 95488 US 95488 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |