MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) 106015 manufactured by Thoratec Corporation.
[187039216]
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
[187039217]
It was reported that the patient reduced rotations per minute (rpm) due to ventricular tachycardia (vt). Log file analysis showed a no external power event due to simultaneous power lead disconnects while the patient was switching power sources. There was no interruption in pump support to the patient during this event. It was later reported that the patient was on oral medication for ventricular tachycardia. Ablation was attempted in the past and was unsuccessful. The patient stated he accidentally disconnected both power leads at one time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01417 |
| MDR Report Key | 9908388 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-31 |
| 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 LVAS IMPLANT KIT (WITH SEALED GRAFTS) |
| Generic Name | VENTRICULAR (ASSISST) BYPASS |
| Product Code | DSQ |
| Date Received | 2020-03-31 |
| Model Number | 106015 |
| Catalog Number | 106015 |
| Operator | LAY USER/PATIENT |
| 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 | 1. Other | 2020-03-31 |